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ROTANTA 460 RF, 100-127V 60Hz 100V 50Hz
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5675-01Ref 5675-51Model 5650, 5660, 5670, 5675
Identity
- Trade Name
- ROTANTA 460 RF, 100-127V 60Hz 100V 50Hz EUDAMEDROTANTA 460 RF FDA UDI
- Generic Name
- Low-speed floor centrifuge, refrigerated FDA UDI
- Device Name
- ROTANTA 460 EUDAMEDFloor standing centrifuge, refrigerated FDA UDI
- Model / Reference
- 5675-01 EUDAMED5650, 5660, 5670, 5675 EUDAMED5675-51 EUDAMEDROTANTA 460 RF - 100V-127V/50-60Hz FDA UDI
- Description
- Floor standing centrifuge, refrigerated FDA UDI
Identifiers
- Catalog Number
- 5675-01 FDA UDI
- Primary DI / UDI-DI
- 04050674078160 EUDAMEDFDA UDI04050674082716 EUDAMED
- Basic UDI-DI
- 040506740100039N EUDAMED
- Direct Marketing DI
- 04050674078160 EUDAMED04050674082716 EUDAMED
- FDA Product Code
- KSO FDA UDI
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
- GMDN Term
- Low-speed floor centrifuge, refrigerated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 864.9275 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
ROTANTA 460 RF, 100-127V 60Hz 100V 50Hz 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 | 040506740100039N | 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 (4)
- EUDAMED 7908613f-2d9f-4137-82e1-b4e838220f08 61 fields · synced Aug 2, 2026
- FDA UDI fa01a3d9-acfc-41e7-9251-6ae50e0e592d 34 fields · synced May 30, 2026
- EUDAMED e3455ce4-7ce8-4b0a-a6c1-33f3d20ed52d 61 fields · synced Jul 27, 2026
- EUDAMED 0326b6ff-25d0-4541-863b-b57e7d97d25e 61 fields · synced Aug 2, 2026