Uromed
by Manish Medi Innovation Private Limited 368 variants
Ref FDS6/1622
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 | Number890615570FDSPH 08906155704430 | Date10 Feb 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- Withdrawn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
- Fascial Dilator Set
- Model / Reference
- FDS6/1622
- Primary DI / UDI-DI
- 08906155704430
- Basic UDI-DI
- 890615570FDSPH
- Direct Marketing DI
- 08906155704430
- EMDN Code
- C9002 Vascular and fascial dilators
- Device Class
- Class IIa
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- IN-MF-000039093
- 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