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Procs Hemispherical Multiaxial Pedicle Screw 5.5x70 / 102.130
EUDAMEDClass IIb (EU MDR)
Ref PKEPV5570
by Ti̇al Med Tibbi̇ Ürünler İç Ve Diş Ti̇caret San. Ltd. Şti̇
Identity
- Trade Name
- PROCS HEMISPHERICAL MULTIAXIAL PEDICLE SCREW 5.5X70 / 102.130 EUDAMED
- Model / Reference
- PKEPV5570 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682162624847 EUDAMED
- Basic UDI-DI
- B-08682162624847 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb 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
Procs Hemispherical Multiaxial Pedicle Screw 5.5x70 / 102.130 by Ti̇al Med Tibbi̇ Ürünler İç Ve Diş Ti̇caret San. Ltd. Şti̇ — Class IIb — MDD — listed in…
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-08682162624847 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000032010
Sources (1)
- EUDAMED 6f315020-4801-471d-a242-82b5997732c1 61 fields · synced Oct 9, 2026