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MEDRAD® MRXperion 250cm Single Patient Disposable
EUDAMEDClass IIa (EU MDR)
Ref XP SP2
Identity
- Trade Name
- MEDRAD® MRXperion 250cm Single Patient Disposable EUDAMED
- Device Name
- MEDRAD® MRXperion Multi-Patient Kit EUDAMED
- Model / Reference
- XP SP2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00616258026596 EUDAMED
- Basic UDI-DI
- 0616258TFCN-0107IIaXR EUDAMED
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MEDRAD® MRXperion 250cm Single Patient Disposable by Bayer Medical Care Inc. — Class IIa — 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-0107IIaXR | Class IIa | 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 64c26ac3-e6df-4cde-869f-937eef2771cd 61 fields · synced Jun 18, 2026