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Drt Plus Poli̇aksi̇yel Li̇stezi̇s Vi̇da 5, 5x20 Mm
EUDAMEDClass IIb (EU MDR)
Ref PRKY-5520
by Doratek Medi̇kal Elektri̇k Maki̇na İmalati Turi̇zm İnşaat San. Ve Ti̇c.ltd.şti̇.
Identity
- Trade Name
- DRT PLUS POLİAKSİYEL LİSTEZİS VİDA 5,5X20 MM EUDAMED
- Device Name
- DRT PLUS POLYAXIAL REDUCTION SCREW 5,5X20 MM EUDAMED
- Model / Reference
- PRKY-5520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681190560042 EUDAMED
- Basic UDI-DI
- B-08681190560042 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS 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
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: Spinal bone screw, non-bioabsorbable
Drt Plus Poli̇aksi̇yel Li̇stezi̇s Vi̇da 5, 5x20 Mm by Doratek Medi̇kal Elektri̇k Maki̇na İmalati Turi̇zm İnşaat San. Ve Ti̇c.ltd.şti̇. — Class IIb — MDD…
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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-08681190560042 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017744
Sources (1)
- EUDAMED 8618ab32-cdb9-4bcd-82e3-24267cb74c06 61 fields · synced Jul 12, 2026