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Rotina 380 Rc Robotic
EUDAMEDClass IVD General (EU MDR)
Ref 3704Ref 3704-11Model 3700, 3704
Identity
- Trade Name
- ROTINA 380 RC ROBOTIC EUDAMED
- Device Name
- ROTINA 380 RC ROBOTIC EUDAMEDROTINA 380 Robotic EUDAMED
- Model / Reference
- 3704 EUDAMED3700, 3704 EUDAMED3704-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050674073264 EUDAMED04050674097963 EUDAMED
- Basic UDI-DI
- B-04050674073264 EUDAMED04050674010019A5 EUDAMED
- Direct Marketing DI
- 04050674097963 EUDAMED
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass 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 IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-04050674073264 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04050674073264 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (2)
- EUDAMED 64a248fc-9a10-4d20-8b4c-eadbc72dcad6 61 fields · synced Aug 2, 2026
- EUDAMED 4ee7356c-16ac-4d60-b12d-cfed82c06d7a 61 fields · synced Aug 2, 2026