Premom Ovulation Test Kit (60 LH + 20 HCG)

FDA UDI

Class II (US FDA UDI)

by Easy Healthcare Corporation

Identity

Trade Name: Premom Ovulation Test Kit (60 LH + 20 HCG) FDA UDI
Generic Name: Natural conception assistance kit FDA UDI
Device Name: Premom 30 LH Ovulation Strips and 10 HCG Pregnancy Strips Kit (60 LH + 20 HCG) FDA UDI
Model / Reference: PM2-S,PM1-S FDA UDI
Description: Premom 30 LH Ovulation Strips and 10 HCG Pregnancy Strips Kit (60 LH + 20 HCG) FDA UDI

Identifiers

Catalog Number: PMS-6020 FDA UDI
Primary DI / UDI-DI: 00855944007338 FDA UDI
FDA Product Code: LCX FDA UDI
CEP 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

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

Premom Ovulation Test Kit (60 LH + 20 HCG) by Easy Healthcare Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Easy Healthcare Corporation

Sources (1)

FDA UDI dd7533d2-0951-4fdc-9c56-ed3b5dcf0dda 34 fields · synced May 30, 2026