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Crosperio RX
EUDAMEDClass IIa (EU MDR)
Ref BD-B25020MRModel Kaneka PTA Balloon Dilatation Catheters
Identity
- Trade Name
- Crosperio RX EUDAMED
- Device Name
- Crosperio RX EUDAMED
- Model / Reference
- BD-B25020MR EUDAMEDKaneka PTA Balloon Dilatation Catheters EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778183780 EUDAMED
- Basic UDI-DI
- B-04540778183780 EUDAMED4993478KNK0013Q 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
Category: Peripheral angioplasty balloon catheter, basic
Crosperio RX by KANEKA Corporation — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- Armada — Abbott Vascular · Class II
- RapidCross — Covidien LP · Class II
- Chocolate PTA Balloon Catheter — TRIREME MEDICAL, LLC · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540778183780 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04540778183780 | Class IIa | Active |
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Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (2)
- EUDAMED 3a0a6214-0246-4b3f-8938-5f781b3f321d 61 fields · synced Jul 31, 2026
- EUDAMED 8fd78cf0-dc22-4496-a34e-5c449b10cee3 61 fields · synced May 19, 2026