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HemoPoint H2 DMS

FDA UDI

Class II (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
HemoPoint H2 DMS FDA UDI
Generic Name
Haemoglobin analyser IVD, point-of-care FDA UDI
Device Name
The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents. FDA UDI
Model / Reference
G3500-001 FDA UDI
Description
The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents. FDA UDI

Identifiers

Catalog Number
G3500-001 FDA UDI
Primary DI / UDI-DI
00657498000199 FDA UDI
FDA Product Code
GKR FDA UDI
GMDN Term
Haemoglobin analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5620 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

HemoPoint H2 DMS by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stanbio Laboratory, L.p.

Sources (1)

  • FDA UDI e767be52-0f80-4f18-aff7-a163c13a6636 36 fields · synced Jun 1, 2026