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Amazewell

FDA UDI

Class I (US FDA UDI)

by Guangzhou Decheng Biotechnology Co., LTD

Identity

Trade Name
Amazewell FDA UDI
Generic Name
Multiple female fertility marker IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Amazewell PdG Urine Test Strip, 5T/Bag FDA UDI
Model / Reference
APDG-5E FDA UDI
Description
Amazewell PdG Urine Test Strip, 5T/Bag FDA UDI

Identifiers

Primary DI / UDI-DI
00850054867469 FDA UDI
FDA Product Code
QKE FDA UDI
GMDN Term
Multiple female fertility marker IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple female fertility marker IVD, kit, rapid ICT, clinical

Amazewell by Guangzhou Decheng Biotechnology Co., LTD — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple female fertility marker IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Guangzhou Decheng Biotechnology Co., LTD

Sources (1)

  • FDA UDI fc906464-f1d4-41f5-ba71-bcb4c339c4ea 33 fields · synced May 30, 2026