← Back to catalogue
Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass IIb (EU MDR)
Ref 40342-13260
Identity
- Trade Name
- GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- PFNA PROXIMAL FEMUR NAIL Ø13X260 mm (TI) EUDAMED
- Model / Reference
- 40342-13260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8680419838153B5 EUDAMED
- Basic UDI-DI
- B-8680419838153B5 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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: Arthrodesis intramedullary nail, non-distracting
Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ — Class IIb — MDD — listed in EUDAMED
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- Reconstruction nail; long, 12×320 mm, 135°, left, cannulated — MEDIN, a.s. · Class IIb
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
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-8680419838153B5 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000016470
Sources (1)
- EUDAMED 285c99df-1bb5-4da6-b4de-6751789398e7 61 fields · synced Sep 26, 2026