Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)
by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi 3 variants
Ref A600 11 100 0000Model A600 11 100 0003
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8698823AFIX00001CH 08698823317003 | Date27 Jan 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Aysam
- Device Name
- Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)Femur-Tibia Standart Klemp (Femur -Tibia Standard Clamp)
- Model / Reference
- A600 11 100 0003, A600 11 100 0000
- Primary DI / UDI-DI
- 08698823317003
- Basic UDI-DI
- 8698823AFIX00001CH, B-08698823317003
- Direct Marketing DI
- 08698823317003
- EMDN Code
- P09120499 External bone fixation systems - other
- Device Class
- Class IClass IIb
- EU market of registration
- AustriaTürkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000017437
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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