← Back to catalogue

HORMONElife™

FDA UDI

Class I (US FDA UDI)

by Wondfo Usa Co., Ltd.

Identity

Trade Name
HORMONElife™ FDA UDI
Generic Name
Multiple female fertility marker IVD, kit, rapid ICT, clinical FDA UDI
Device Name
HORMONElife™ PdG Urine Test Strip OTC 6PK FDA UDI
Model / Reference
W199-S-6BX FDA UDI
Description
HORMONElife™ PdG Urine Test Strip OTC 6PK FDA UDI

Identifiers

Primary DI / UDI-DI
00816862027266 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

No

FDA UDI

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

HORMONElife™ 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Wondfo Usa Co., Ltd.

Sources (1)

  • FDA UDI d8d4560f-0982-47c7-bf10-35de6ce29c47 35 fields · synced May 30, 2026