Alt Baldirlik
by Orsa Ortopedi Medikal Ozel Egitim Hizm.san.tic.ltd.sti.
Part of a family of 22 devices: see the family page
Ref N-39S
Alt Baldirlik (N-39S) is a Class I device made by Orsa Ortopedi Medikal Ozel Egitim Hizm.san.tic.ltd.sti., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 869758481ORSAOSNTPVK), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number869758481ORSAOSNTPVK 08697584816848 | Date2 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 869758481ORSAOSNTPVK
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- Withdrawn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
- Orsa Sports One Size Neopren
- Model / reference
- N-39S
- Primary DI / UDI-DI
- 08697584816848
- Basic UDI-DI
- 869758481ORSAOSNTPVK
- EMDN code
- Y061299 Lower extremity orthoses - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- TR-MF-000015873
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