Gorset wysoki tułowia ze stalkami 32 cm
by ORTHO24 Spółka Z Ograniczoną Odpowiedzialnością 6 variants
Ref OT32 CZARNY XL, OT32 CZARNY XXXL, OT32 BEŻ S, OT32 CZARNY S, OT32 BEŻ XXXL, OT32 BEŻ L, OT32 BEŻ 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 | Number59049170981005WN | 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- Withdrawn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
- Gorset
- Model / Reference
- OT32 CZARNY XL, OT32 CZARNY XXXL, OT32 BEŻ S, OT32 CZARNY S, OT32 BEŻ XXXL, OT32 BEŻ L, OT32 BEŻ XL
- Primary DI / UDI-DI
- 05904917098950, 05904917098974, 05904917098868, 05904917098929, 05904917098912, 05904917098882, 05904917098899
- Basic UDI-DI
- 59049170981005WN
- Direct Marketing DI
- 05904917098950059049170989740590491709886805904917098929059049170989120590491709888205904917098899
- EMDN Code
- Y060308 Lumbosacral spine orthoses
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000034742
Other devices from ORTHO24 Spółka Z Ograniczoną Odpowiedzialnością
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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