Smilereader Ovulation test kit(30LH+10HCG)

FDA UDI

Class I (US FDA UDI)

by Equinox Biotech Co., Ltd.

Identity

Trade Name: Smilereader Ovulation test kit(30LH+10HCG) FDA UDI
Generic Name: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Device Name: The convenience kit consisiting of 30 Ovulation Test device and 10 Pregnancy Test devices. FDA UDI
Model / Reference: 81026 FDA UDI
Description: The convenience kit consisiting of 30 Ovulation Test device and 10 Pregnancy Test devices. FDA UDI

Identifiers

Primary DI / UDI-DI: 06938444981026 FDA UDI
FDA Product Code: OIE FDA UDI
GMDN Term: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.3250 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

Yes

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: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Natural conception assistance kit

Smilereader Ovulation test kit(30LH+10HCG) by Equinox Biotech Co., Ltd. — Class I — 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
Easy@Home Ovulation Test Strip (50 tests kit) — EASY HEALTHCARE CORPORATION · Class I
Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
Kroger — KROGER CO., THE · Class I
H.E.B — H. E. BUTT GROCERY COMPANY · Class I
Equate — Walmart Stores · 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 I	Pending data

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

Manufacturer

Manufacturer: Equinox Biotech Co., Ltd.

Sources (1)

FDA UDI 59fc767d-7816-4bf0-aba2-eba59424ed2b 34 fields · synced May 30, 2026