← Back to catalogue
Crosperio RX
EUDAMEDClass IIa (EU MDR)
Ref BD-B25020LRModel Kaneka PTA Balloon Dilatation Catheters
Identity
- Trade Name
- Crosperio RX EUDAMED
- Device Name
- Crosperio RX EUDAMED
- Model / Reference
- Kaneka PTA Balloon Dilatation Catheters EUDAMEDBD-B25020LR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778183834 EUDAMED
- Basic UDI-DI
- 4993478KNK0013Q EUDAMEDB-04540778183834 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Crosperio RX by KANEKA Corporation — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4993478KNK0013Q | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4993478KNK0013Q | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (2)
- EUDAMED 5319daf4-e27b-466c-b5a3-f77684947834 61 fields · synced Jul 9, 2026
- EUDAMED b050b17d-3002-4eb9-bfcc-bc7666105be9 61 fields · synced May 16, 2026