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Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass IIb (EU MDR)
Ref 21162-35028
Identity
- Trade Name
- GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- LOCKING CANNULATED SCREW 3.5 X 28 mm (TI) EUDAMED
- Model / Reference
- 21162-35028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8680419862042AJ EUDAMED
- Basic UDI-DI
- B-8680419862042AJ EUDAMED
- EMDN Code
- P09120603 CANNULATED SCREWS 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
Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ — 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-8680419862042AJ | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000016470
Sources (1)
- EUDAMED 2960f469-7b1d-4f15-b5cf-98c41a5ddb75 61 fields · synced Sep 26, 2026