OBR4 Xxxl
by ORTHO24 Spółka Z Ograniczoną Odpowiedzialnością
Ref OBR4 XXXL
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 | Number59049170981003WJ 05904917098738 | Date12 Nov 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- Withdrawn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
- Orteza na ramię i bark
- Model / Reference
- OBR4 XXXL
- Primary DI / UDI-DI
- 05904917098738
- Basic UDI-DI
- 59049170981003WJ
- Direct Marketing DI
- 05904917098738
- EMDN Code
- Y060627 Shoulder-elbow - wrist orthoses
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000034742
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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