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Fixter
EUDAMEDClass IIb (EU MDR)
Ref SCS2512
by Yaylamed Tıbbı Cihazlar Medikal ve Teknolojik Ürünler Ltd. Şti.
Identity
- Trade Name
- Fixter EUDAMED
- Device Name
- Sternal Closure Plate EUDAMED
- Model / Reference
- SCS2512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TRMF000015947SCS2512HR EUDAMED
- Basic UDI-DI
- B-TRMF000015947SCS2512HR EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthopaedic fixation plate, non-bioabsorbable
Fixter by Yaylamed Tıbbı Cihazlar Medikal ve Teknolojik Ürünler Ltd. Şti. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-TRMF000015947SCS2512HR | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000015947
Sources (1)
- EUDAMED 2019e00e-7978-4e86-9c71-36823c16caae 61 fields · synced Oct 7, 2026