Identity
- Device Name
- 4U SPINAL TRANSVERSE CONNECTOR 70 mm EUDAMED
- Model / Reference
- 2500070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682376505246 EUDAMED
- Basic UDI-DI
- B-08682376505246 EUDAMED
- EMDN Code
- P09070304 SPINE FIXATION SYSTEM CONNECTORS 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
Category: Bone-screw internal spinal fixation system connector
4U SPINAL TRANSVERSE CONNECTOR 70 mm by 4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti. — Class IIb — MDD — listed in EUDAMED
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Also classified as Bone-screw internal spinal fixation system connector.
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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-08682376505246 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000040424
Sources (1)
- EUDAMED 88dd2b19-7ecd-4206-8b02-367ac8ea72ab 61 fields · synced Oct 7, 2026