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TST External Fixator System
EUDAMEDClass IIb (EU MDR)
Ref 41522000040Model PIN FIXATION BOLT
Identity
- Trade Name
- TST External Fixator System EUDAMED
- Device Name
- POLYAXIAL PIN FIXATION BOLT TITANIUM (40MM POLYGONAL) EUDAMED
- Model / Reference
- PIN FIXATION BOLT EUDAMED41522000040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680858480203 EUDAMED
- Basic UDI-DI
- B-08680858480203 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-08680858480203 | 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 894eb5aa-9a29-49dd-ba81-c0edef9641de 61 fields · synced Sep 17, 2026