Clinisafe
Ref 01315-XS, 01315-M, 01315-XL, 01315M, 01315-L, 01315S, 01315XL, 01315XS
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8029686EXAMGLOVENSNAF | Date7 Aug 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- CLINISAFE 01315 - Guanto in nitrile senza polvere monouso sterile
- Model / Reference
- 01315-XS, 01315-M, 01315-XL, 01315M, 01315-L, 01315S, 01315XL, 01315XS
- Primary DI / UDI-DI
- 08029686212943, 08029686212912, 08029686212936, 08029686210512, 08029686212905, 08029686210529, 08029686210536, 08029686210543
- Basic UDI-DI
- 8029686EXAMGLOVENSNAF
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000007798
Other devices from Clini-Lab SRL
Properties
Other properties (13)
- Sterile: No
- 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