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ROTANTA 460 R, 100-127V 60Hz 100V 50Hz
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5660-01Ref 5660-51Model 5650, 5660, 5670, 5675
Identity
- Trade Name
- ROTANTA 460 R, 100-127V 60Hz 100V 50Hz EUDAMEDROTANTA 460 FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- ROTANTA 460 EUDAMEDTabletop centrifuge FDA UDI
- Model / Reference
- 5660-01 EUDAMED5650, 5660, 5670, 5675 EUDAMED5660-51 EUDAMEDROTANTA 460 R - 100V-127V/50-60Hz FDA UDI
- Description
- Tabletop centrifuge FDA UDI
Identifiers
- Catalog Number
- 5660-01 FDA UDI
- Primary DI / UDI-DI
- 04050674057639 EUDAMEDFDA UDI04050674059053 EUDAMED
- Basic UDI-DI
- 040506740100039N EUDAMED
- Direct Marketing DI
- 04050674057639 EUDAMED04050674059053 EUDAMED
- FDA Product Code
- KSO FDA UDI
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
- GMDN Term
- General-purpose centrifuge IVD 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 R, 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 25d9e51e-bfab-451c-b3fc-2e09c8e40c1b 61 fields · synced Jul 16, 2026
- FDA UDI c03a15da-95c8-4f57-bbec-714cd523fe7a 34 fields · synced May 30, 2026
- EUDAMED fbf55cb5-07d6-412b-b653-93ea1c0e3a56 61 fields · synced Jun 18, 2026
- EUDAMED fd2dc57c-50d2-40c0-bef7-25222975fb9c 61 fields · synced Jul 16, 2026