← Back to catalogue
ROTIXA 500 RS, 208V 60Hz
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 4950-08Model 4950
Identity
- Trade Name
- ROTIXA 500 RS, 208V 60Hz EUDAMEDROTIXA 500 RS FDA UDI
- Generic Name
- Blood bank centrifuge FDA UDI
- Device Name
- ROTIXA 500 RS EUDAMEDFloor standing centrifuge for preparation of cell concentrate and/or plasma concentrate FDA UDI
- Model / Reference
- 4950 EUDAMED4950-08 EUDAMEDROTIXA 500, Standard FDA UDI
- Description
- Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate FDA UDI
Identifiers
- Catalog Number
- 4950-08 FDA UDI
- Primary DI / UDI-DI
- 04050674076302 EUDAMEDFDA UDI
- Basic UDI-DI
- 040506740100029L EUDAMED
- Direct Marketing DI
- 04050674076302 EUDAMED
- FDA Product Code
- QBV 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
ROTIXA 500 RS, 208V 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 | 040506740100029L | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Andreas Hettich GmbH
- EUDAMED SRN
- DE-MF-000010680
Sources (3)
- EUDAMED 85d80af2-c671-42d2-8ac0-020d9cd48b84 61 fields · synced Jun 19, 2026
- FDA UDI 18e3a395-692d-43d9-84b1-cd546af24b31 34 fields · synced May 29, 2026
- EUDAMED 5362a465-b00f-4e6f-ad07-850c9e888a09 61 fields · synced Jun 19, 2026