D.T3-01
Ref DT3-01 SXV.L, DT3-01 SXV.S, DT3-01 SXV.M, DT3-01 DXV.XL, DT3-01 SXV.XL
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 | Number803348865Y06060301CS | Date1 Sep 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- Withdrawn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
- Ortesi per Dita - Dita
- Model / Reference
- DT3-01 SXV.L, DT3-01 SXV.S, DT3-01 SXV.M, DT3-01 DXV.XL, DT3-01 SXV.XL
- Primary DI / UDI-DI
- 08054729354151, 08054729354175, 08054729354168, 08054729354144, 08054729354182
- Basic UDI-DI
- 803348865Y06060301CS
- EMDN Code
- Y060603 Fingers orthoses
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000043862
Other devices from F.G.P. s.r.l.
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