Identity
- Trade Name
- 406 EUDAMED
- Device Name
- 416 EUDAMED
- Model / Reference
- centrifuge EUDAMEDGZ-406B(IVD) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800160700206 EUDAMED
- Basic UDI-DI
- 88001607IVDJQCM9 EUDAMED
- EMDN Code
- W02069003 CENTRIFUGES 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General-purpose centrifuge IVD
406 by Gyrozen — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 88001607IVDJQCM9 | Class A | Active |
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Manufacturer
- Manufacturer
- Gyrozen
- EUDAMED SRN
- KR-MF-000021591
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 0e46c4ca-2650-4111-ba9e-427b3cd15810 61 fields · synced Jun 19, 2026