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HemoSmart GOLD
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref S25009, S25032, S25033
Identity
- Trade Name
- HemoSmart GOLD EUDAMED
- Device Name
- HemoSmart GOLD Hemoglobin Screening System EUDAMED
- Model / Reference
- S25009, S25032, S25033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487606A06A EUDAMED
- Basic UDI-DI
- B-47136487606A06A EUDAMED
- EMDN Code
- W010106010801,W0101060199,W0201069099 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
Yes
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-47136487606A06A | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 8d83e31a-33b3-4ccf-a649-e637615152b8 61 fields · synced Jun 18, 2026
- EUDAMED 8d83e31a-33b3-4ccf-a649-e637615152b8-1 61 fields · synced Jun 10, 2026