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Ortimplant
EUDAMEDClass IIb (EU MDR)
Ref O1863538
by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi
Identity
- Trade Name
- Ortimplant EUDAMED
- Device Name
- 3,5 MM KANÜLLÜ VİDA TAMAMI YİVLİ KİLİTLİ ÇELİK (3,5 MM CANNULATED SCREW FULL THREADED LOCKING SS) 38 MM EUDAMED
- Model / Reference
- O1863538 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680941125271 EUDAMED
- Basic UDI-DI
- B-08680941125271 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
Ortimplant by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi — Class IIb — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
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- 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-08680941125271 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017438
Sources (1)
- EUDAMED 017d6f36-7026-46b1-afdc-b4af4e972a2c 61 fields · synced Oct 7, 2026