A na-akọ na Haiyan Kangyuan Medical Instrument Co., Ltd. enwetala akwụkwọ ikike CE nke EU Medical Device Regulation 2017/745 (nke a na-akpọ "MDR") na ngwaahịa abụọ n'ọnwa gara aga. Ngwaahịa a bụ PVC Laryngeal Mask Airways na Latex Foley Catheters maka otu ojiji. Ka ọ dị ugbu a, ngwaahịa 12 nke Kangyuan Medical agafeela akwụkwọ MDR, nke bụ ndị a:
[Ụkpụrụ Endotracheal maka otu ojiji];
[Sterile Suction Catheters maka otu ojiji];
[Oxygen Masks maka otu ojiji];
[Nasal Oxygen Cannulas maka otu ojiji];
[Guedel Airways maka otu ojiji];
[Laryngeal Mask Airways];
[Nkpuchi Anesthesia maka otu ojiji];
[Ihe nzacha iku ume maka otu ojiji];
[Sekit iku ume maka otu ojiji];
[Mmiri Urinary maka otu ojiji (Foley)];
[Latex Foley Catheters maka otu ojiji];
[PVC Laryngeal Mask Airways]
Akwụkwọ EU MDR na-egosi na ngwaahịa ahụike Kangyuan na-emezu ihe achọrọ nke iwu ngwaọrụ ahụike EU ọhụrụ 2017/745 ma nwee ọnọdụ ohere kachasị ọhụrụ maka ahịa EU. Nke a abụghị naanị nnabata dị elu nke ịdị mma, nchekwa na ịdị irè nke ngwaahịa ọgwụ Kangyuan, mana ọ bụkwa ihe ngosipụta dị mkpa nke ike teknụzụ nke ụlọ ọrụ na asọmpi ahịa. Kangyuan Medical ga-ewere ohere a iji gbasaa ahịa Europe ma nye ọtụtụ ndị ọrịa gburugburu ụwa ọrụ ahụike dị elu.
Oge nzipu: Ọgọst-19-2024