Hemoglobin Test Strip

FDA UDI

Class II (US FDA UDI)

by Urit Medical Electronic Co., Ltd.

Identity

Trade Name: Hemoglobin Test Strip FDA UDI
Generic Name: Haemoglobin detection IVD, reagent FDA UDI
Model / Reference: PH 01;25pieces/vial×2/box FDA UDI

Identifiers

Primary DI / UDI-DI: 06935740726993 FDA UDI
FDA Product Code: GGM FDA UDI
GMDN Term: Haemoglobin detection IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.8625 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Haemoglobin detection IVD, reagent

Hemoglobin Test Strip by Urit Medical Electronic Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Haemoglobin detection IVD, reagent.

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Hemoglobin Test Strip — Urit Medical Electronic Co., Ltd. · Class II
Hemoglobin Test Strip — Urit Medical Electronic Co., Ltd. · 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: Urit Medical Electronic Co., Ltd.

Sources (1)

FDA UDI 2e5b937b-5521-4647-9537-46e4473c73ad 33 fields · synced May 30, 2026