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: 5-Strip HCG Pregnancy Tests,20-Strip LH-Ovulation Test, and 25 Plastic Urine Cups FDA UDI
Model / Reference: WS-H5L20 FDA UDI
Description: 5-Strip HCG Pregnancy Tests,20-Strip LH-Ovulation Test, and 25 Plastic Urine Cups FDA UDI

Identifiers

Primary DI / UDI-DI: 00816862024357 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

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

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Also classified as Natural conception assistance kit.

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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

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Manufacturer

Manufacturer: Wondfo Usa Co., Ltd.

Sources (1)

FDA UDI 691a91d4-549b-45e3-8b1b-4a72d0d2656e 35 fields · synced May 30, 2026