← Back to catalogue
Fixter
EUDAMEDClass IIb (EU MDR)
Ref SCS4512Ref SCS3512Ref SCS4012
by Yaylamed Tıbbı Cihazlar Medikal ve Teknolojik Ürünler Ltd. Şti.
Identity
- Trade Name
- Fixter EUDAMED
- Device Name
- Sternal Closure Plate EUDAMED
- Model / Reference
- SCS4512 EUDAMEDSCS3512 EUDAMEDSCS4012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TRMF000015947SCS4512J7 EUDAMEDD-TRMF000015947SCS3512HY EUDAMEDD-TRMF000015947SCS4012HE EUDAMED
- Basic UDI-DI
- B-TRMF000015947SCS4512J7 EUDAMEDB-TRMF000015947SCS3512HY EUDAMEDB-TRMF000015947SCS4012HE 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
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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-TRMF000015947SCS4512J7 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000015947
Sources (3)
- EUDAMED b81dd33e-30b0-47ac-8e44-43bdfbe73bca 61 fields · synced Oct 6, 2026
- EUDAMED 136974ac-aa34-415b-ace7-389de1392307 61 fields · synced May 17, 2026
- EUDAMED 0772e072-50b8-4911-a12a-d0ae6db4935a 61 fields · synced May 18, 2026