Champion PTCA Guide Wire
Ref PTCA-CAR-J-HY-EF-H-014-195Model Champion PTCA Guide Wire
Active
CE MDR
Valid until
6 Feb 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5710086-GWC2J2 05710086048630 | Date28 Aug 2026 | StatusActive |
Certificates
- IZ 2320977-3 Active
Technical documentation EU MDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 7 Feb 2023
- Expires
- 6 Feb 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
EU market availability
Made available in 1 country, as listed in EUDAMED:
- Greece since 1 Jun 2022
Specification
- Model / Reference
- Champion PTCA Guide Wire, PTCA-CAR-J-HY-EF-H-014-195
- Primary DI / UDI-DI
- 05710086048630
- Basic UDI-DI
- 5710086-GWC2J2
- EMDN Code
- C04010201 Coronary artery therapeutic guidewires, hydrophilic
- Device Class
- Class III
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- DK-MF-000019782
Other devices from SP Medical A/S
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