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Roto Silenta 630 Rs
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5005-50Model 5005Ref 5005-90Ref 5005-08
Identity
- Trade Name
- ROTO SILENTA 630 RS EUDAMEDFDA UDI
- Generic Name
- Blood bank centrifuge FDA UDI
- Device Name
- ROTO SILENTA 630 RS EUDAMEDFloor standing centrifuge for preparation of cell concentrate and/or plasma concentrate, nitrogen purging FDA UDIFloor standing centrifuge for preparation of cell concentrate and/or plasma concentrate FDA UDI
- Model / Reference
- 5005 EUDAMED5005-50 EUDAMED5005-90 EUDAMED5005-08 EUDAMEDROTO SILENTA 630 RS, Standard Hz/Kü FDA UDIROTO SILENTA 630 RS STANDARD FDA UDI
- Description
- Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate, nitrogen purging FDA UDIFloor standing centrifuge for preparation of cell concentrate and/or plasma concentrate FDA UDI
Identifiers
- Catalog Number
- 5005-50 FDA UDI5005 FDA UDI5005-08 FDA UDI
- Primary DI / UDI-DI
- 04050674031158 EUDAMEDFDA UDI04050674031479 EUDAMEDFDA UDI04050674031172 EUDAMED04050674031141 EUDAMEDFDA UDI
- Basic UDI-DI
- 040506740100019J EUDAMED
- Direct Marketing DI
- 04050674031158 EUDAMED04050674031479 EUDAMED04050674031172 EUDAMED04050674031141 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
No
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 Rs by Andreas Hettich GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 040506740100019J | 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 (11)
- EUDAMED 07f5afba-bccb-4a5d-9cba-b545f2161414 61 fields · synced Sep 18, 2026
- EUDAMED 39de7a33-5068-4503-b3fc-f63c22385fa3 61 fields · synced May 18, 2026
- EUDAMED 69e6238a-9fb9-44ef-a189-368ae512ab2a 61 fields · synced May 18, 2026
- EUDAMED 529707cb-3ebc-419f-bd4e-318c54a12e92 61 fields · synced May 18, 2026
- FDA UDI a2f32a82-e71d-4a5b-8b86-91efb0376677 34 fields · synced May 30, 2026
- FDA UDI 9136ca90-d8cf-48c5-957f-24ddd74872eb 34 fields · synced May 30, 2026
- FDA UDI 83958759-9e24-4f37-9134-e2b078d1b46c 34 fields · synced May 30, 2026
- EUDAMED 23afb420-0c7f-4c6e-b3d1-b695c128c633 61 fields · synced Jul 11, 2026
- EUDAMED 25b16f15-3c69-488e-9370-453efb207c50 61 fields · synced Jul 13, 2026
- EUDAMED 6cbf2e5f-635a-46d2-8545-fcc29b039e24 61 fields · synced Jul 27, 2026
- EUDAMED e280d473-203f-4ab3-ac4a-cc7c63f573ae 61 fields · synced Sep 18, 2026