Wedge NC Scoring Balloon Dilatation Catheter
by BrosMed Medical Co., Ltd 108 variants
Ref 814-2220
Active
CE MDR CE MDD
Valid until
4 Aug 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR.2292-2026/0057 | Date5 Aug 2026 | StatusActive |
| European Union | CE/MDD | NumberB-06958481453171 06958481453171 | Date25 Aug 2022 | StatusActive |
Certificates
- MDR.2292-2026/0057 Active
Technical documentation EU MDR
- Certifier
- UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
- Issued
- 5 Aug 2026
- Expires
- 4 Aug 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- Wedge NC
- Device Name
- Wedge NC Scoring Balloon Dilatation Catheter
- Model / Reference
- 814-2220
- Primary DI / UDI-DI
- 06958481453171
- Basic UDI-DI
- B-06958481453171, 695848140005LZ
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU 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
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