Taiwan FDA registration 49d7e948c2b5de3ed83559adea750282

"Speed" medical stereoscopic N95 mask (unsterilized)

TW: "飛速" 醫用立體N95口罩(未滅菌)

Taiwan·Risk Class 1·Shenzhonghai Medical Inc.;; AOK Tooling Ltd.·Registered Jan 25, 2018 – Jan 25, 2028Active

Registration details

Analysis ID: 49d7e948c2b5de3ed83559adea750282
Customs Code: DHA09600334206

Company information

Manufacturer: Shenzhonghai Medical Inc.;; AOK Tooling Ltd.
Manufacturer Country: China
Authorized Representative: AOK MEDTECH INC.

Product details

Intended Use: Limited to the first level identification range of medical equipment classification and grading management measures "Medical clothing (I.4040)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4040 Clothing for medical purposes
Import Information: Contract manufacturing;; Input;; Chinese goods

Dates and status

Registration Date: Jan 25, 2018
Expiry Date: Jan 25, 2028

About this record

Access comprehensive regulatory information for "Speed" medical stereoscopic N95 mask (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 49d7e948c2b5de3ed83559adea750282 and manufactured by Shenzhonghai Medical Inc.;; AOK Tooling Ltd.. The authorized representative in Taiwan is AOK MEDTECH INC..

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