Aysam
by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi 1,000+ variants
Ref A600 11 100 0004Model 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/MDR | NumberB-08698823317430 08698823317430 | Date3 Dec 2024 | StatusActive |
| European Union | CE/MDD | NumberB-08698823317430 08698823317430 | Date3 Dec 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Ayfix Di̇nami̇k Aksi̇yel Ayakbi̇leği̇ Hari̇ci̇ Fixator Uzun Sol (Ayfix Dynamic Axial Ankle Fixator in Adults Long Left)Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)
- Model / Reference
- A600 11 100 0004, A600 11 100 0003
- Primary DI / UDI-DI
- 08698823317430
- Basic UDI-DI
- B-08698823317430, 8698823AFIX00001CH
- Direct Marketing DI
- 08698823317430
- EMDN Code
- P09120499 External bone fixation systems - other
- Device Class
- Class IIbClass I
- EU market of registration
- TürkiyeAustria
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