Guidewire
by Shanghai INT Medical Instruments Co., Ltd. China EUDAMED
Ref GW359JFModel 0.018", 0.021", 0.025", 0.028", 0.032", 0.035", 0.038"
EMDN C04020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69509009CEAGWMN | Date24 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Guidewire
- Model / Reference
- 0.018", 0.021", 0.025", 0.028", 0.032", 0.035", 0.038", GW359JF
- Primary DI / UDI-DI
- 06950900958878
- Basic UDI-DI
- 69509009CEAGWMN
- EMDN Code
- C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000009966
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 98c79ab7-7789-4411-a5e3-2dbf7ee1f5d4