Wondfo

FDA UDI

Class II (US FDA UDI)

by Wondfo Usa Co., Ltd.

Identity

Trade Name: Wondfo FDA UDI
Generic Name: Natural conception assistance kit FDA UDI
Device Name: 10+25 Strip Combo; 10 hCG Pregnancy Test + 25 LH Ovulation FDA UDI
Model / Reference: WS-H10L25-CA FDA UDI
Description: 10+25 Strip Combo; 10 hCG Pregnancy Test + 25 LH Ovulation FDA UDI

Identifiers

Primary DI / UDI-DI: 00816862026719 FDA UDI
FDA Product Code: LCX FDA UDI
NGE FDA UDI
GMDN Term: Natural conception assistance kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1155 FDA UDI
862.1485 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Natural conception assistance kit

Wondfo by Wondfo Usa Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Natural conception assistance kit.

Dr. Talbot's — TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS LLC · Class I
Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) — EASY HEALTHCARE CORPORATION · Class II
Topcare — Topco Associates, LLC · Class I
PREGABLE Ovulation Test Kit — Equinox Biotech Co., Ltd. · Class I
DAVID — Equinox Biotech Co., Ltd. · Class I
Smilereader ovulation test kit — Equinox Biotech Co., Ltd. · Class I
Easy@Home Ovulation Test Strip (50 tests kit) — EASY HEALTHCARE CORPORATION · Class I
Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Wondfo Usa Co., Ltd.

Sources (1)

FDA UDI 188bcdcc-0012-4ced-a0dd-9eb66a9099b0 35 fields · synced May 30, 2026