Identity
- Trade Name
- ROTINA 380 RC Robotic EUDAMED
- Device Name
- ROTINA 380 Robotic EUDAMED
- Model / Reference
- 3700, 3704 EUDAMED3704-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050674097956 EUDAMED
- Basic UDI-DI
- 04050674010019A5 EUDAMED
- Direct Marketing DI
- 04050674097956 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 380 RC Robotic 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 | 04050674010019A5 | Class A | Active |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (1)
- EUDAMED de05a4a9-1da5-46da-815a-9ffa29c830ed 61 fields · synced Jun 18, 2026