HAIYAN KANGYUAN MEDICAL INSTRUMENT CO., LTD.

Likitan Kangyuan ya sami nasarar samun takardar shaidar MDR

Haiyan Kangyuan Medical Kayan aiki Co., Ltd. ya samu nasarar samun ka'idojin kayan aikin likitancin EU (EU 2017/745, ana kiranta da "MDR") takardar shaidar a ranar 1 ga Fabrairu, 2023, lambar takardar shaidar ita ce 6122159CE01, kuma iyakokin takaddun shaida sun haɗa da Endotracheal Tubes don Amfani guda ɗaya, Batir Stude Catheter don Amfani da Single Oxy, Canjin Amfani da Single Oxy, Canjin Amfani da Single Oxy. Guedel Airways don Amfani Guda, Laryngeal Mask Airways, Masks na Anesthesia don Amfani Guda, Tace Mai Numfashi don Amfani Guda, Wuraren Numfashi don Amfani Guda.

 

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An ba da rahoton cewa Dokar Kayan Aikin Kiwon Lafiya ta EU MDR (EU 2017/745) ta fara aiki a ranar 25 ga Mayu, 2017, ta maye gurbin Dokar Kayan Aikin Kiwon Lafiyar MDD (93/42/EEC) da AIMDD (90/385/EEC) da AIMDD (90/385/EEC) na kayan aikin likita mai aiki, da nufin samar da ingantaccen tsarin kiwon lafiya da daidaita tsarin kiwon lafiya. jama'a da marasa lafiya. Daga cikin su, MDR ta gabatar da tsauraran buƙatu don masana'antun kayan aikin likitanci dangane da sarrafa haɗarin samfur, aikin samfur da ƙa'idodin aminci, kimantawa na asibiti, da faɗakarwar bayan kasuwa da kulawa. Idan aka kwatanta da umarnin MDD, hukumar ta MDR tana da kulawa mai ƙarfi, takaddun shaida mai wahala, da kuma mai da hankali kan aminci da ingancin kayayyakin.

Kangyuan Medical ya samu nasarar samun takardar shaidar MDR a wannan karon, wanda ya tabbatar da cewa kayayyakin Kangyuan sun kai ga amincewa da EU da kasuwanni na kasa da kasa dangane da sarrafa samar da kayayyaki, tabbatar da inganci da kuma kula da haɗari.

Ga Kangyuan Medical, wanda ya kasance mai zurfi a cikin kasuwannin Turai fiye da shekaru goma, samun takardar shaidar MDR wani ci gaba ne. , Latin Amurka da sauran kasuwanni sun ba da tallafi mai karfi.


Lokacin aikawa: Fabrairu-06-2023