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Neon
EUDAMEDClass III (EU MDR)
Ref BS-10008FModel Kaneka PTCA Balloon Dilatation Catheters
Identity
- Trade Name
- NEON EUDAMED
- Device Name
- NEON EUDAMED
- Model / Reference
- Kaneka PTCA Balloon Dilatation Catheters EUDAMEDBS-10008F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778147744 EUDAMED
- Basic UDI-DI
- B-04540778147744 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III 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
Neon by KANEKA Corporation — Class III — 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-04540778147744 | Class III | 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 (1)
- EUDAMED d9d76413-a2da-4d60-ba56-b6264c24b523 61 fields · synced Jun 19, 2026