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ROTANTA 460, 100-127V 50-60Hz
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5650-01Model 5650, 5660, 5670, 5675
Identity
- Trade Name
- ROTANTA 460, 100-127V 50-60Hz EUDAMEDROTANTA 460 FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- ROTANTA 460 EUDAMEDTabletop centrifuge FDA UDI
- Model / Reference
- 5650-01 EUDAMED5650, 5660, 5670, 5675 EUDAMEDROTANTA 460 - 100V-127V/50-60Hz FDA UDI
- Description
- Tabletop centrifuge FDA UDI
Identifiers
- Catalog Number
- 5650-01 FDA UDI
- Primary DI / UDI-DI
- 04050674057622 EUDAMEDFDA UDI
- Basic UDI-DI
- 040506740100039N EUDAMED
- Direct Marketing DI
- 04050674057622 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- General-purpose centrifuge IVD 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
ROTANTA 460, 100-127V 50-60Hz 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 (3)
- EUDAMED 464201ad-9bc0-4d46-a564-171a02f2d232 61 fields · synced Jun 19, 2026
- FDA UDI 8a6a81ab-1283-49e7-bd09-5c53e57f1217 34 fields · synced May 30, 2026
- EUDAMED 02205d9f-b4de-4397-8f08-b64ca0a5ec95 61 fields · synced Jun 19, 2026