Identity
- Trade Name
- HumaReader HS EUDAMED
- Device Name
- HumaReader HS EUDAMED
- Model / Reference
- 16670 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04033145185727 EUDAMED
- Basic UDI-DI
- 04033145EL16670K4 EUDAMED
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
HumaReader HS by Human Gesellschaft für Biochemica und Diagnostica mbH — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 04033145EL16670K4 | Class A | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000025590
Sources (1)
- EUDAMED c2811ed2-61de-420e-8e1b-4be2f6d6c74b 61 fields · synced Jul 17, 2026