Identity
- Trade Name
- ROTOLAVIT II-S EUDAMED
- Device Name
- ROTOLAVIT II-S, 100-240V, 50-60HZ, OHNE ROTOR EUDAMED
- Model / Reference
- 1008-00S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640173554004 EUDAMED
- Basic UDI-DI
- 07640173551008-00S49 EUDAMED
- EMDN Code
- W02069003 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
No
EUDAMED
New Device
No
EUDAMED
Category: General-purpose centrifuge IVD
Rotolavit Ii-S by Hettich AG — Class A — IVDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 07640173551008-00S49 | Class A | Active |
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Manufacturer
- Manufacturer
- Hettich AG
- EUDAMED SRN
- CH-MF-000041657
- Authorised Representative
- Andreas Hettich GmbH DE-AR-000016247
Sources (1)
- EUDAMED 9af2c54e-d3cc-46dc-b455-86c86f7b1572 61 fields · synced Jun 18, 2026