← Back to catalogue

HemoSmart GOLD

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref S5640254, S5640365, S5640733, S5640255, S5640682, S5640745Ref S5800112 

by Apex Biotechnology Corp.

Identity

Trade Name
HemoSmart GOLD EUDAMED
Device Name
HemoSmart GOLD hemoglobin test strips EUDAMED
HemoSmart GOLD hemoglobin control solution EUDAMED
Model / Reference
S5640254, S5640365, S5640733, S5640255, S5640682, S5640745 EUDAMED
S5800112 EUDAMED

Identifiers

Primary DI / UDI-DI
D-47136487606AHT2F EUDAMED
D-47136487606AHS2D EUDAMED
Basic UDI-DI
B-47136487606AHT2F EUDAMED
B-47136487606AHS2D EUDAMED
EMDN Code
W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

HemoSmart GOLD by Apex Biotechnology Corp. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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

Manufacturer

Manufacturer
Apex Biotechnology Corp.
EUDAMED SRN
TW-MF-000019773
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (3)

  • EUDAMED 98faca80-e07e-4431-946a-fc5ab276dd72 61 fields · synced Jul 30, 2026
  • EUDAMED 80229f11-2ebc-45ef-be40-8710042dcee8 61 fields · synced May 18, 2026
  • EUDAMED 98faca80-e07e-4431-946a-fc5ab276dd72-1 61 fields · synced Jun 10, 2026