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Rotanta 460 Robotic, 110-120v 50-60hz
EUDAMEDClass IVD General (EU MDR)
Ref 5680-11-RS232Model 5680
Identity
- Trade Name
- ROTANTA 460 ROBOTIC, 110-120V 50-60HZ EUDAMED
- Device Name
- ROTANTA 460 ROBOTIC, 110-120V 50-60HZ EUDAMEDROTANTA 460 Robotic EUDAMED
- Model / Reference
- 5680-11-RS232 EUDAMED5680 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050674062640 EUDAMED
- Basic UDI-DI
- B-04050674062640 EUDAMED040506740100179Z EUDAMED
- Direct Marketing DI
- 04050674062640 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
Rotanta 460 Robotic, 110-120v 50-60hz 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-04050674062640 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04050674062640 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (2)
- EUDAMED 7ad19f07-6158-4169-913e-7ac06afdc974 61 fields · synced Jun 18, 2026
- EUDAMED 6f653062-fa25-4036-aa79-c1316f6bfc12 61 fields · synced Jun 18, 2026