Aysam
by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi 1,000+ variants
Ref A600 11 005 0007Model A600 11 100 0003
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 | Number8698823AFIX00001CH 08698823373979 | Date27 Jan 2026 | 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- Withdrawn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
- Ayfix Dinamik Aksiyel Harici Fixator Femur -Tibia Standart (Ayfix Dynamic Axial External Fixator for Femur -Tibia Standard)
- Model / Reference
- A600 11 100 0003, A600 11 005 0007
- Primary DI / UDI-DI
- 08698823373979
- Basic UDI-DI
- 8698823AFIX00001CH
- Direct Marketing DI
- 08698823373979
- EMDN Code
- P09120499 External bone fixation systems - other
- Device Class
- Class I
- EU market of registration
- Austria
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