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Wondfo

FDA UDI

Class I (US FDA UDI)

by Wondfo Usa Co., Ltd.

Identity

Trade Name
Wondfo FDA UDI
Generic Name
Multiple female fertility marker IVD, kit, rapid ICT, clinical FDA UDI
Device Name
5-Strip; PDG Progesterone test FDA UDI
Model / Reference
DW199-S-5BX-A FDA UDI
Description
5-Strip; PDG Progesterone test FDA UDI

Identifiers

Primary DI / UDI-DI
00816862024081 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

No

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

No

FDA UDI

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

Wondfo by Wondfo Usa 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
Wondfo Usa Co., Ltd.

Sources (1)

  • FDA UDI 1ce39bc6-0945-48f2-ad6d-48e605eadaf2 35 fields · synced Jun 8, 2026