UCSol™ DEBRIDEMENT, 500 mL
Ref 95170, 95170FModel 95160
Active
CE MDR CE MDD
Valid until
9 Jul 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-08033976721336 08033976721336 | Date23 Jul 2026 | StatusActive |
| European Union | CE/MDD | NumberB-08033976721336 08033976721336 | Date23 Jul 2026 | StatusActive |
Certificates
- EPT 0477.MDR.23/5201.1 Active
Quality management system EU MDR
- Certifier
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 30 Nov 2023
- Expires
- 9 Jul 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- UCSol™ DEBRIDEMENT, 500 mLUCSol Debridement
- Model / Reference
- 95170, 95160, 95170F
- Primary DI / UDI-DI
- 08033976721336
- Basic UDI-DI
- B-08033976721336, 803397672SOL951606570XT
- EMDN Code
- M040499 Dressings for wounds, sores and ulcerations - other
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000020870
Other devices from WELCARE INDUSTRIES S.p.A.
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