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TST Anatomic Pressfit System
EUDAMEDClass III (EU MDR)
Ref 11378105860Model INSERT
Identity
- Trade Name
- TST Anatomic Pressfit System EUDAMED
- Device Name
- INSERT FOR ANAT. PRESS FIT CUP 10° 36x58-60 MM UHMWPE EUDAMED
- Model / Reference
- INSERT EUDAMED11378105860 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680858473083 EUDAMED
- Basic UDI-DI
- B-08680858473083 EUDAMED
- EMDN Code
- P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES INSERTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TST Anatomic Pressfit System by Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08680858473083 | Class III | Active |
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Manufacturer
- Manufacturer
- Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇.
- EUDAMED SRN
- TR-MF-000017767
Sources (1)
- EUDAMED ede548a2-0c8a-44db-9268-e76925ac9799 61 fields · synced Jul 18, 2026