Identity
- Trade Name
- MEDRAD® Vflow Disposable Hand Controller EUDAMED
- Device Name
- MEDRAD® Mark 7 Arterion Injection System EUDAMED
- Model / Reference
- VF HC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00616258024257 EUDAMED
- Basic UDI-DI
- 0616258TFCN-0081IIbYU EUDAMED
- EMDN Code
- Z11039013 ANGIOGRAPHIC INJECTORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MEDRAD® Vflow Disposable Hand Controller by Bayer Medical Care Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0616258TFCN-0081IIbYU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
- EUDAMED SRN
- US-MF-000007050
- Authorised Representative
- Bayer Medical Care B.V. NL-AR-000000240
Sources (1)
- EUDAMED 3f645a5f-b896-45d4-83c7-ee84e33c6b28 61 fields · synced Jul 26, 2026