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TST External Fixator System
EUDAMEDClass IIb (EU MDR)
Ref 44140000001Model RAIL CLAMP
Identity
- Trade Name
- TST External Fixator System EUDAMED
- Device Name
- PEDIATRIC RAIL CLAMP EUDAMED
- Model / Reference
- RAIL CLAMP EUDAMED44140000001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680858407545 EUDAMED
- Basic UDI-DI
- B-08680858407545 EUDAMED
- EMDN Code
- P09120499 EXTERNAL BONE FIXATION SYSTEMS - OTHER 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
TST External Fixator System by Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇. — Class IIb — 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-08680858407545 | 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 f1b21b18-9888-4526-a31a-ae55f43aa54a 61 fields · synced Aug 1, 2026