Guidewires for Central Circulatory Application
by EPflex Feinwerktechnik GmbH EUDAMED
Active
Ref TEZ-035-275-30
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000265993 | Date27 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1000266008 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 27 Oct 2025
- Expires
- 2 Jul 2029
- 1000265993 Issued
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 27 Oct 2025
- Expires
- 8 Nov 2028
Specification
- Device Name
- Guidewires for Central Circulatory Application
- Model / Reference
- TEZ-035-275-30
- Primary DI / UDI-DI
- 04255605601367
- Basic UDI-DI
- 42556056gwcIIIEH
- EMDN Code
- C04010202 Coronary artery therapeutic guidewires, non-hydrophilic
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005425
Other devices from Epflex Feinwerktechnik GmbH
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No