The announce that national medicines and chemical reagents supervises management board to control sampling observation outcome about releasing national medical apparatus and instruments (the 6th)
(2018 the 79th)
Control government to enhance quality of medical apparatus and instruments, use safety of product of safeguard medical apparatus and instruments is effective, chance of treatment of laser of conductor of half-and-half of organization of total bureau of supervisory government of medicines and chemical reagents of former state provision, abnormal asks 19 variety such as equipment of groove, ophthalmic laser 892 batches (stage) the product undertook quality supervises sampling observation, in all 61 batches (stage) the product does not accord with a standard to set. Particular case announcement is as follows:
One, the product of medical apparatus and instruments that is notted agree with to add up to a standard to set by sampling observation project, 16 variety that involve 33 companies 38 batches (stage) .
Specific for:
(one) chance of semiconductor laser treatment 7 enterprises 9 products. INTERMEDIC ARFRAN S.A. Laser of a semiconductor treats appearance (procuratorial: Shanghai cypress jumps over limited company of medical treatment equipment) , bide one's time / power of output of terminal of wavelengh of preparation, laser, laser does not accord with a standard to set; The engine of treatment of laser of a semiconductor that state is capable laser technology limited company produces Shanghai, pulse duration (pulse width) do not accord with a standard to set; The engine of treatment of laser of a semiconductor that state is capable laser technology limited company produces Shanghai, duration of the accuracy that controls parts of an apparatus and appearance, pulse (pulse width) do not accord with a standard to set; The engine of treatment of laser of a semiconductor that state is capable laser technology limited company produces Shanghai, duration of power of output of terminal of the accuracy that successive leakage current and patient assist parts of an apparatus of electric current, control and appearance, laser, pulse (pulse width) do not accord with a standard to set; The laser of a semiconductor that IRIDEX Corporation produces treats appearance [procuratorial: With instrument of division forest medical treatment (Shanghai) limited company] , duration of the accuracy that controls parts of an apparatus and appearance, pulse (pulse width) do not accord with a standard to set; The laser of a semiconductor that limited company of development of technology of Guangzhou city Kang Zheng economy produces treats appearance, laser timer equipment does not accord with a standard to set; The laser of a semiconductor that limited company of liability of medicine of Mu of division of Russia A Er produces treats appearance [procuratorial: Science and technology of Heilongjiang Kang Heng expands limited company] , interlocking connector does not accord with remote control standard regulation; The laser of a semiconductor that limited company of Shenzhen city Ji Sidi science and technology produces treats appearance, urgent laser is stopped implement do not accord with a standard to set; The light of laser of an ophthalmic semiconductor that QUANTEL MEDICAL produces coagulates machine (procuratorial: Beijing Gao Shiyuan hopes science and technology is finite liability company) , laser terminal outputs power not to accord with a standard to set.
(2) supersonic Duopule is fetal tutelar equipment an enterprise a product. The embryo admires 1 when limited company of medical apparatus and instruments produces medical service of Tai'an city peaceful supersonic Duopule in the heart, output supersonic power, power input not to accord with a standard to set.
(3) abnormal asks slot an enterprise 2 batch product. The Shanghai 2 batch that Inc. of material science and technology produces Aimengdi abnormal asks slot, dimension (groovy channel channel of long, chamfer trench of wide, chamfer is deep) do not accord with a standard to set.
(4) α - hydroxyl man acerbity dehydrogenation is enzymatic (HBDH) determine reagent box an enterprise 1 batch product. Chongqing is medium the 1 batch α of production of yuan of biology technology limited company - enzymatic check of hydroxide man acerbity dehydrogenation checks agent box (rate law) , linear does not accord with a standard to set.
(5) vertical vapour sterilization implement 1 enterprise a product. Sterilization of vapour of pressure of a LDZH-100KBS that factory of Shanghai Shen An medical apparatus and instruments produces vertical implement, sample is examining normally cannot work normally in the process.
(6) dilator of vagina of one-time use asepsis an enterprise 1 batch product. Changzhou city annulus health the 1 batch that limited company of medical apparatus and instruments produces is one-time dilator of use asepsis vagina, fight be out of shape ability does not accord with a standard to set.
(7) metallic femur neck secures a hammer 2 enterprises 2 batch product. Suzhou is small helix of hollow bolt pressurization nails the 1 batch that starts production of limited company of science and technology of rachis scar medical treatment, exterior surface roughness does not accord with a standard to set; The 1 batch that TREU Instrumente GmbH produces is hollow bolt of set a bone [procuratorial: General (Shanghai) limited company of medical treatment equipment] , dimension does not accord with a standard to set.
(8) bolt of metallic set a broken bone 3 enterprises 3 batch product. The 1 batch double lock of production of limited company of institute of medical treatment of Shenyang East Asia finalizes the design set a broken bone of metal of arch of orbit tine type pressurization board fixed system component, anxious the bolt of set a broken bone of 1 batch metal that makes production of limited company of equipment of medical treatment of city new harbor, Suzhou revive, dimension does not accord with a standard to set.
(9) injector of one-time use asepsis (take an injection) 2 enterprises 2 batch product. Injector of one-time use asepsis takes the 1 batch that medical and implemental limited company produces Changchun Jin Kangyuan needle, inject needle dimension does not accord with a standard to set; Injector of one-time use asepsis takes the 1 batch that limited company of equipment of medical treatment of saline city new triumph produces needle, join firmness does not accord with a standard to set.
(10) dynamoelectric operating-table 2 enterprises 2 products. Chongqing arranges a dynamoelectric operating-table that limited company of medical apparatus and instruments produces beautiful auspicious, sample is examining normally cannot work normally in the process; 1 when limited company of development of comfortable science and technology of Hefei and Er produces dynamoelectric hydraulic pressure are muti_function operating-table, power input does not accord with a standard to set.
(11) the operation is only 2 enterprises 2 batch product. Jilin nots the 1 batch that limited company of science and technology of bright medical treatment produces is one-time use hole towel, bilge broken intensity, dry state (product key area) ; Bilge broken intensity, wet condition (product key area) ; Tensile strength, dry state (product key area) do not accord with a standard to set; The 1 batch that limited company of things of Medical Protection of Nanchang city rising sun produces is one-time use operation is only, tensile strength, dry state (the product is not crucial area) do not accord with a standard to set.
(12) oxygen of one-time use bazoo runs 3 companies 3 batch product. Oxygen of one-time use bazoo provides each 1 batch that emperor of Suzhou new developed area amounts to city of wholesome equipment limited company, Yangzhou to always install limited company of medical apparatus and instruments to produce, sealing does not accord with a standard to set; Guangzhou your spring forest the 1 batch that limited company of medical apparatus and instruments produces is one-time urticant canal of bazoo of type of use an organic whole, asepsis does not accord with a standard to set.
(13) dentistry mobile phone 2 enterprises 2 products. The mobile phone of dentistry of turbine of a low speed that limited company of equipment of division of beautiful elegant tine produces division of Fosan city Nanhai, sample is examining normally cannot work normally in the process; The tooth of turbine of a high speed that limited company of science and technology of Guangdong elegant medical treatment produces gets a mobile phone, rotate speed does not accord with a standard to set.
(14) medical aerobic concentrator (medical the machine that make oxygen) an enterprise a product. 1 when Inc. of science and technology of health care of Henan god travel produces small-sized elements sift the machine that make oxygen, oxygen chroma does not accord with a standard to set.
(15) ophthalmic laser equipment 4 enterprises 4 products. The light of laser of an ophthalmic semiconductor that QUANTEL MEDICAL produces coagulates machine (procuratorial: Beijing Gao Shiyuan hopes science and technology is finite liability company) , the ophthalmoscope of scanning of a laser that OPTOS PLC produces (procuratorial: Beijing Gao Shiyuan hopes science and technology is finite liability company) , laser power / the accuracy of energy does not accord with a standard to set; 1 when Heidelberg Engineering GmbH produces in all scanner of anxious laser fault (procuratorial: Beijing Gao Shiyuan hopes science and technology is finite liability company) , power input does not accord with a standard to set; The Nd:Y of a pulse that limited company of equipment of electron of laser of Wuhan Bo Dakang producesChance of cure of path of AG laser tear, power of the accuracy of working data, laser / the accuracy of energy does not accord with a standard to set.
(16) medical microtherm box an enterprise 2 products. Bay 2 low temperature that Inc. of Ma stalking or branch produces save box, power source does not accord with a standard to set.
Above sampling observation does not accord with standard compasses a system of fixed quotas for grain production to taste particular case, see accessory 1.
2, the product of medical apparatus and instruments that is notted agree with to add up to a standard to set for the project such as label label, manual by sampling observation project, 6 variety that involve 32 companies 33.
Specific for:
(one) chance of semiconductor laser treatment 19 enterprises 19 products. Trade of division of treasure of Beijing be good at crane limited company, INTERMEDIC ARFRAN S.A. (procuratorial: Shanghai cypress jumps over limited company of medical treatment equipment) , Shenzhen day base Inc. of group of authority health science and technology, Fotona D.o.o. (procuratorial: Limited company of technology of Beijing Fang Tailun medical treatment) , IRIDEX Corporation [procuratorial: With instrument of division forest medical treatment (Shanghai) limited company] , Shanghai radium good fortune is limited company of equipment of health medical treatment, great Heng Xinji yuan the laser of each 1 semiconductor that Inc. of science and technology produces treats appearance, a Shanghai semiconductor laser of production of state is capable laser technology limited company treats machine, QUANTEL MEDICAL (procuratorial: Beijing Gao Shiyuan hopes science and technology is finite liability company) light of laser of an ophthalmic semiconductor coagulates machine, mark does not accord with a standard to set; The laser of each 1 semiconductor that Guangzhou city Kang Zheng develops rich of limited company, Wuhan to stimulate limited company of century science and technology to produce via aid technology treats appearance, the exterior mark of equipment or equipment component, mark does not accord with a standard to set; The laser of a semiconductor that limited company of liability of medicine of Mu of division of Russia A Er produces treats appearance (procuratorial: Science and technology of Heilongjiang Kang Heng expands limited company) , the exterior mark of equipment or equipment component, operation instruction handbook, mark does not accord with a standard to set; The laser of a semiconductor that the laser of a semiconductor that express type that limited company produces Hua Anke skill of peaceful state city treats limited company of science and technology of Hua Xin medical treatment of city of appearance, Tianjin to produce treats appearance, operation instruction handbook, mark does not accord with a standard to set; Limited company of technology of laser of Shanghai cure shellfish, Shanghai the laser of each 1 semiconductor that limited company produces electricity treats Mandisenguang machine, EUFOTON S.R.L (procuratorial: Shanghai actor blessing tells limited company of medical treatment equipment) , the laser of each 1 semiconductor that limited company of group of science and technology of medical treatment of Fujian Province people produces treats appearance, Wuhan to surprise the laser of a semiconductor that causes production of laser technology Inc. depilates appearance, the exterior mark of equipment or equipment component does not accord with a standard to set.
(2) supersonic Duopule is fetal tutelar equipment 3 enterprises 3 products. The embryo admires 1 when limited company of equipment of medical treatment of heavy allusion of Shenzhen city and heart produces portable Duopule in the heart, 1 when limited company of instrument of Shenzhen city Bei Siman nicety produces supersonic Duopule appearance of fetal heart sounds, the exterior mark of equipment or equipment component does not accord with a standard to set; Shenzhen Beijing cypress appearance of 1 when limited company of medical treatment equipment produces supersonic and fetal custody, technical specification does not accord with a standard to set.
(3) without achieve measure tonometer automatically (electronic tonometer) 2 enterprises 2 products. An electron tonometer that company of German Beurer GmbH produces, the manual does not accord with a standard to set; Guangzhou city be good at the tonometer of electron of an arm type that limited company of abstruse science and technology produces, the label of equipment of batteries power supply does not accord with a standard to set.
(4) medical and supersonic atomizer an enterprise a product. Medical treatment of Jiangsu Fu Lin sets 1 when have limited company is produced supersonic atomizer, the exterior mark of equipment or equipment component does not accord with a standard to set.
(5) medical aerobic concentrator (medical the machine that make oxygen) an enterprise a product. 1 when limited company of science and technology of peaceful of Shenyang love Er produces medical molecular sieve makes oxygen machine, exterior mark does not accord with a standard to set.
(6) ophthalmic laser equipment 7 enterprises 7 products. The Nd:Y of a pulse that limited company of equipment of laser of Er of benefit of Wuhan city brilliant producesChance of cure of path of AG laser tear, the exterior mark of equipment or equipment component does not accord with a standard to set; 1 when Heidelberg Engineering GmbH produces in all scanner of anxious laser fault (procuratorial: Beijing Gao Shiyuan hopes science and technology is finite liability company) , the ophthalmoscope of scanning of a laser that OPTOS PLC produces (procuratorial: Beijing Gao Shiyuan hopes science and technology is finite liability company) , TOPCON MEDICAL LASER SYSTEMS, INC. Light of an ophthalmic laser coagulates machine (procuratorial: Ma of Ao Tengsai case (China) group limited company) , the exterior mark of equipment or equipment component, mark does not accord with a standard to set; The light of laser of an ophthalmic semiconductor that QUANTEL MEDICAL produces coagulates machine (procuratorial: Beijing Gao Shiyuan hopes science and technology is finite liability company) , an ophthalmic Nd:Y that Meridian AG producesTimes frequency laser treats VO appearance [procuratorial: Trade of classics of east love general (Beijing) limited company] , data of the exterior mark of equipment or equipment component, mark, user does not accord with a standard to set; The Nd:Y of a pulse that limited company of equipment of electron of laser of Wuhan Bo Dakang producesChance of cure of path of AG laser tear, data of the exterior mark of equipment or equipment component, user does not accord with a standard to set.
Above sampling observation does not accord with standard compasses a system of fixed quotas for grain production to taste particular case, see accessory 2.
3, 15 breed that sampling observation project accords with the product of medical apparatus and instruments that the standard provides to involve 429 companies entirely 831 batches (stage) , see accessory 3.
4, do not accord with a standard to provide a product to what discover in afore-mentioned sampling observation, total bureau of supervisory government of medicines and chemical reagents of former state provision already asked enterprise seat is provincial supervisory management department of food medicines and chemical reagents supervises and urge relevant enterprise according to " medical apparatus and instruments monitors regulation " " recall of medical apparatus and instruments runs way " wait for code the product that regulations asks not to accord with a standard to set to sampling observation undertakes the risk is evaluated, determine recall level according to the serious degree of blemish of medical apparatus and instruments, active recall product publishs recall information. In the meantime, the enterprise should find out a product as soon as possible unqualified reason, make rectify and reform measure and rectify and reform on schedule reach the designated position, about deal with circumstance on September 15, 2018 forward the society is announced, seasonable will relevant circumstance reports to seat provincial food medicines and chemical reagents supervises management department.
5, supervisory management department of provincial food medicines and chemical reagents answers enterprise seat relevant enterprise undertakes investigating handling, undertake to the enterprise product recall, unqualified reason is investigated, fulfil rectify and reform the circumstance such as measure and public exposure information to undertake supervisory; The product causes harm to perhaps evidence proves the likelihood endangers human body health to human body, should accept suspension lawfully production, manage, use urgent control measure; Need suspends an import, answer to sign up for national medicines and chemical reagents in time to supervise management board to make administration handle a decision. The enterprise did not fulfil afore-mentioned requirements by the requirement, supervisory management department of provincial food medicines and chemical reagents should investigate seat gravely lawfully. Concerned information should be made public in time to the society.
6, above fulfils a circumstance each, medicines and chemical reagents of relevant and provincial food supervises management department to control management board at medicines and chemical reagents of nation of the report before September 21, 2018.
Accessory:
Sampling observation of 1. country medical apparatus and instruments does not accord with a standard to provide product list
Sampling observation of 2. country medical apparatus and instruments (the project such as label label manual) do not accord with a standard to provide product list
Sampling observation of 3. country medical apparatus and instruments accords with a standard to provide product list
