Identity
- Trade Name
- HumaLyzer 4000 EUDAMED
- Device Name
- HumaLyzer 4000 EUDAMED
- Model / Reference
- 18250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04033145192305 EUDAMED
- Basic UDI-DI
- 04033145CC18250DZ 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
- Netherlands 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 4000 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 | 04033145CC18250DZ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- DE-MF-000025590
Sources (1)
- EUDAMED a5900b34-5910-45d4-ab7c-f587e506a986 61 fields · synced Jul 9, 2026