Identity
- Trade Name
- ROTO SILENTA 630 RS EUDAMED
- Device Name
- ROTO SILENTA 630 RS EUDAMED
- Model / Reference
- 5005 EUDAMED5005-80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050674031295 EUDAMED
- Basic UDI-DI
- 040506740100019J EUDAMED
- Direct Marketing DI
- 04050674031295 EUDAMED
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Roto Silenta 630 Rs by Andreas Hettich GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 040506740100019J | Class IIa | Active |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (2)
- EUDAMED b67a292b-7e3f-42f4-8ae5-769d3fe5e5fb 61 fields · synced Jun 19, 2026
- EUDAMED b2e0490a-1e04-4213-987f-840600008643 61 fields · synced Jun 19, 2026