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Neon
EUDAMEDClass III (EU MDR)
Ref BS-37520Model Kaneka PTCA Balloon Dilatation Catheters
Identity
- Trade Name
- NEON EUDAMED
- Device Name
- NEON EUDAMED
- Model / Reference
- Kaneka PTCA Balloon Dilatation Catheters EUDAMEDBS-37520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540778148413 EUDAMED
- Basic UDI-DI
- B-04540778148413 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
Category: Coronary angioplasty balloon catheter, cutting/scoring
Neon by KANEKA Corporation — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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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-04540778148413 | 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 deab83b5-00a8-459c-8778-319b0a22a68e 61 fields · synced Jun 19, 2026