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Rotina 380 Robotic
EUDAMEDClass IVD General (EU MDR)
Ref 3700-01Ref 3700Model 3700, 3704
Identity
- Trade Name
- ROTINA 380 ROBOTIC EUDAMED
- Device Name
- ROTINA 380 ROBOTIC EUDAMED
- Model / Reference
- 3700-01 EUDAMED3700 EUDAMED3700, 3704 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050674084475 EUDAMED04050674073240 EUDAMED
- Basic UDI-DI
- B-04050674084475 EUDAMEDB-04050674073240 EUDAMED04050674010019A5 EUDAMED
- Direct Marketing DI
- 04050674073240 EUDAMED04050674084475 EUDAMED
- EMDN Code
- W02069003 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
Category: General-purpose centrifuge IVD
Rotina 380 Robotic by Andreas Hettich GmbH — Class IVD General — IVDR, IVDD — 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
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-04050674084475 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04050674084475 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (4)
- EUDAMED 76b35cb7-7785-4f24-808c-3cc73e0b6c2f 61 fields · synced Jul 10, 2026
- EUDAMED d7ab733b-b613-4cb1-90aa-62f486a70792 61 fields · synced May 18, 2026
- EUDAMED ac6d3ed4-e72c-4436-a0d4-9de77442f67c 61 fields · synced Jun 19, 2026
- EUDAMED 0641a4d9-1f46-47b4-85e8-62afeb43350e 61 fields · synced Jul 10, 2026