Wedge NC
by BrosMed Medical Co., Ltd China EUDAMED
Ref 814-3225
EMDN C010401020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number695848140005LZ | Date20 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Certificates
- MDR.2292-2026/0057 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2292
- Issued
- 5 Aug 2026
- Expires
- 4 Aug 2031
Specification
- Device Name
- Wedge NC Scoring Balloon Dilatation Catheter
- Model / Reference
- 814-3225
- Primary DI / UDI-DI
- 06958481453591
- Basic UDI-DI
- 695848140005LZ
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000007501
- Authorised representative
- Brosmed Medical B.V. NL-AR-000002616
Other devices from BrosMed Medical Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 955a7566-3471-4789-99af-f6f10b4d6b12