Identity
- Trade Name
- ROTINA 420 R, 200-240V 50Hz EUDAMED
- Device Name
- ROTINA 420 / 420 R EUDAMED
- Model / Reference
- 4701, 4706 EUDAMED4706 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050674036092 EUDAMED
- Basic UDI-DI
- 040506740100159V EUDAMED
- Direct Marketing DI
- 04050674036092 EUDAMED
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
New Device
No
EUDAMED
ROTINA 420 R, 200-240V 50Hz by Andreas Hettich GmbH — 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 | 040506740100159V | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (1)
- EUDAMED 541a31b7-7444-4bf7-8169-2f026332ac28 61 fields · synced Jun 18, 2026