Ao-91A L
by Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇
Ref AO-91A LModel ORTHOPEDICS BACK AND WAIST ORTHOSIS
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 | Number86803954ORT05X5 08680395425125 | Date9 Apr 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- Withdrawn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
- Orthopedics Back and Waist Orthosis
- Model / Reference
- ORTHOPEDICS BACK AND WAIST ORTHOSIS, AO-91A L
- Primary DI / UDI-DI
- 08680395425125
- Basic UDI-DI
- 86803954ORT05X5
- Direct Marketing DI
- 08680395425125
- EMDN Code
- Y060318 Cervicothoracolumbosacral spine orthoses
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000046503
Other devices from Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇
See all devices from Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇ →
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