Aysam
by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi 1,000+ variants
Ref A411 20 080 0000Model A600 11 100 0003
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8698823AFIX00001CH 08698823314033 | 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- Withdrawn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, A411 20 080 0000
- Primary DI / UDI-DI
- 08698823314033
- Basic UDI-DI
- 8698823AFIX00001CH
- Direct marketing DI
- 08698823314033
- EMDN code
- P09120499 External bone fixation systems - other
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- TR-MF-000017437
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Properties
Other properties (13)
- Supplied sterile: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No