AddWire
by Lake Region Medical Inc. EUDAMED
Active
Ref SCMBN-084V
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081634901ExtensionGWNE | Date9 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- AddWire Extension Wire
- Model / Reference
- SCMBN-084V
- Primary DI / UDI-DI
- 00816349014246
- Basic UDI-DI
- 081634901ExtensionGWNE
- EMDN Code
- C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000033013
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Lake Region Medical
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