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4U SPINAL POSTERIOR MULTIFUNCTIONAL PEDICLE SCREW Ø:8.0 L100mm
EUDAMEDClass IIb (EU MDR)
Ref 1208010
Identity
- Device Name
- 4U SPINAL POSTERIOR MULTIFUNCTIONAL PEDICLE SCREW Ø:8.0 L100mm EUDAMED
- Model / Reference
- 1208010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682376509442 EUDAMED
- Basic UDI-DI
- B-08682376509442 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
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
4U SPINAL POSTERIOR MULTIFUNCTIONAL PEDICLE SCREW Ø:8.0 L100mm by 4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti. — Class IIb — MDD — listed in EUDAMED
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-08682376509442 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000040424
Sources (1)
- EUDAMED 11518e56-8348-4e25-bc3b-35a57bf94019 61 fields · synced Oct 7, 2026