Finger Immobilizer Brace (Right), Size 3
by Private Enterprise Toros-Group
Ref Type 557R-3Model Type 557R
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number482011408557RW4 04820114091857 | Date3 Nov 2026 | 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- Withdrawn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
- Finger Immobilizer Brace (Right)
- Model / reference
- Type 557R, Type 557R-3
- Primary DI / UDI-DI
- 04820114091857
- Basic UDI-DI
- 482011408557RW4
- Direct marketing DI
- 04820114091857
- EMDN code
- Y060603 Fingers orthoses
- Device class
- Class I
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- UA-MF-000051136
- Authorised representative
- Medtex Sp. z o.o. PL-AR-000009252
Other devices from Private Enterprise Toros-Group
Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No