Hydrophilic coating Guidewire
by Shanghai INT Medical Instruments Co., Ltd.
Ref HG181SFModel 0.018" , 0.025", 0.028", 0.032", 0.038"
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69509009CEGWSG 06950900919435 | Date25 Mar 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Guidewire
- Model / Reference
- 0.018", 0.025", 0.028", 0.032", 0.038", HG181SF
- Primary DI / UDI-DI
- 06950900919435
- Basic UDI-DI
- 69509009CEGWSG
- EMDN Code
- C04020101 Peripheral vascular diagnostic guidewires, hydrophilic
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009966
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shanghai INT Medical Instruments Co., Ltd.
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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