Hydrophilic Guidewire
by Hunan Reborn Medical Science and Technology Development Co., Ltd 7 variants
Model 0.025inch,0.028inch,0.032inch,0.035inch,0.038inch
Active
CE MDD
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/MDD | NumberB-CNMF000023648HGU0602UN D-CNMF000023648HGU0602UN | Date31 Jul 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- 0.025inch, 0.028inch, 0.032inch, 0.035inch, 0.038inch
- Primary DI / UDI-DI
- D-CNMF000023648HGU0602UN
- Basic UDI-DI
- B-CNMF000023648HGU0602UN
- EMDN Code
- U0602 Urological guidewires, not hydrophilic
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000023648
- Authorised representative
- MedPath GmbH DE-AR-000000087
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Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No