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Wedge NC Scoring Balloon Dilatation Catheter
EUDAMEDClass III (EU MDR)
Ref 814-2725
Identity
- Device Name
- Wedge NC Scoring Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 814-2725 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958481453393 EUDAMED
- Basic UDI-DI
- B-06958481453393 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Coronary angioplasty balloon catheter, cutting/scoring
Wedge NC Scoring Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06958481453393 | Class III | Active |
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Manufacturer
- Manufacturer
- BrosMed Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000007501
- Authorised Representative
- Brosmed Medical B.V. NL-AR-000002616
Sources (1)
- EUDAMED 453f47a8-1aab-4eac-8963-635ab58ea8a9 61 fields · synced Jun 18, 2026