Identity
- Trade Name
- Rotaflow II Drive (Flex) EUDAMED
- Device Name
- Rotaflow II Drive (Flex) EUDAMED
- Model / Reference
- 701074622 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058863229263 EUDAMED
- Basic UDI-DI
- B-04058863229263 EUDAMED
- EMDN Code
- C030199 EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rotaflow II Drive (Flex) by Maquet Cardiopulmonary GmbH — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04058863229263 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (1)
- EUDAMED 0f8cc506-8916-4dda-a6d3-49f8f29725ba 61 fields · synced Oct 6, 2026