Identity
- Trade Name
- ROTO SILENTA 630 R, STANDARD EUDAMEDROTO SILENTA 630 RS FDA UDI
- Generic Name
- Blood bank centrifuge FDA UDI
- Device Name
- ROTO SILENTA 630 R, STANDARD EUDAMEDFloor standing centrifuge for preparation of cell concentrate and/or plasma concentrate FDA UDI
- Model / Reference
- 5005-10 EUDAMEDROTO SILENTA 630 RS STANDARD FDA UDI
- Description
- Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate FDA UDI
Identifiers
- Catalog Number
- 5005-10 FDA UDI
- Primary DI / UDI-DI
- 04050674030748 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050674030748 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
- GMDN Term
- Blood bank centrifuge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Roto Silenta 630 R, Standard by Andreas Hettich GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04050674030748 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (2)
- EUDAMED d54a3e6d-51c2-40d0-9d0a-e4fe1ba6a19a 61 fields · synced Jun 17, 2026
- FDA UDI 3cdd6fa0-de48-4252-ad4e-d88bd607aafc 34 fields · synced May 30, 2026