Identity
- Trade Name
- HumaLyzer Primus EUDAMED
- Device Name
- HumaLyzer Primus EUDAMED
- Model / Reference
- 18200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04033145118664 EUDAMED
- Basic UDI-DI
- 04033145CC18200DJ EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Hungary 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
HumaLyzer Primus 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 | 04033145CC18200DJ | Class A | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000025590
Sources (1)
- EUDAMED 28c6cab7-0dc8-4102-a65f-3e6bf1258b3b 61 fields · synced Jul 28, 2026