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TST Ulnar Intramedullary Nails
EUDAMEDClass IIb (EU MDR)
Ref 80520200040Model ULNA NAIL
Identity
- Trade Name
- TST Ulnar Intramedullary Nails EUDAMED
- Device Name
- ULNA INTER FIX NAIL (TI) Ø 4 X 200 MM EUDAMED
- Model / Reference
- ULNA NAIL EUDAMED80520200040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698673427020 EUDAMED
- Basic UDI-DI
- B-08698673427020 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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
Category: Arthrodesis intramedullary nail, non-distracting
TST Ulnar Intramedullary Nails by Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
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-08698673427020 | Class IIb | 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 c9d2dca7-0b70-4e07-b8e9-2557fb5683f3 61 fields · synced Oct 7, 2026