Accoat Guide Wire
by SP Medical A/S 447 variants
Ref S-C-018-70Model Accoat Guide Wire
Expiring
CE MDR
Valid until
28 Mar 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5710086-GWACJU 05710086002625 | Date12 May 2026 | StatusActive |
Certificates
- IZ 2320977-1 Expiring
Technical documentation EU MDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 7 Jul 2022
- Expires
- 28 Mar 2027
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Model / Reference
- Accoat Guide Wire, S-C-018-70
- Primary DI / UDI-DI
- 05710086002625
- Basic UDI-DI
- 5710086-GWACJU
- EMDN Code
- C04010202 Coronary artery therapeutic guidewires, non-hydrophilic
- Device Class
- Class III
- EU market of registration
- Denmark
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