Aysam
by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi 1,000+ variants
Ref A600 11 115 0000Model A600 11 100 0003
Active
CE MDR CE MDD
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/MDD | Number8698823AFIX00001CH 08698823379636 | Date27 Jan 2026 | StatusActive |
| European Union | CE/MDR | Number8698823AFIX00001CH 08698823379636 | 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- Withdrawn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/MDD, CE/MDR Active
Specification
- Device Name
- Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)Çok Eksenli̇ Femur Tibia Hari̇ci̇ Fi̇ksatör (Polyaxial Femur Tibia External Fixator)
- Model / Reference
- A600 11 100 0003, A600 11 115 0000
- Primary DI / UDI-DI
- 08698823379636
- Basic UDI-DI
- 8698823AFIX00001CH, B-08698823379636
- Direct Marketing DI
- 08698823379636
- 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
Other devices from Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi
See all devices from Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi →
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