Ao-63 3XL
by Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇ Türkiye EUDAMED
Ref AO-63 3XLModel ORTHOPEDICS BACK AND WAIST ORTHOSIS EMDN Y060318
Overview
The AO-63 3XL is a high-quality orthopedic back and waist orthosis designed to provide comfortable, secure, and effective support for patients with back pain or other musculoskeletal conditions. This innovative device features [REPROCESSED], ensuring precise sterilization and sterility, and meets the latest standards for medical devices. The AO-63 3XL is ideal for professional use in clinics, hospitals, and home healthcare settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number86803954ORT05X5 | Date9 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Orthopedics Back and Waist Orthosis
- Model / Reference
- ORTHOPEDICS BACK AND WAIST ORTHOSIS, AO-63 3XL
- Primary DI / UDI-DI
- 08680395404748
- Basic UDI-DI
- 86803954ORT05X5
- Direct Marketing DI
- 08680395404748
- EMDN Code
- Y060318 Cervicothoracolumbosacral spine orthoses
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000046503
Other devices from Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 2957b346-7e5a-40a3-a9d5-9e0b37665a48