Sunmed™ Guide wires
by Sunny Medical Device (Shenzhen) Co.Ltd EUDAMED
Active
Ref SM-GW-1.5J35260PN-TP
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number694735850003L9 | Date10 Feb 2025 | 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- Withdrawn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
- Guide Wires
- Model / Reference
- SM-GW-1.5J35260PN-TP
- Primary DI / UDI-DI
- 06947358515807
- Basic UDI-DI
- 694735850003L9
- EMDN Code
- C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
- Device Class
- Class IIa
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000022722
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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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