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Ortimplant
EUDAMEDClass IIb (EU MDR)
Ref O100 03 070 2028
by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi
Identity
- Trade Name
- Ortimplant EUDAMED
- Device Name
- KIRSCHNER TELİ DELİCİ UÇLU ÇELİK (KIRSCHNER WIRE WITH TROCAR POINT SS) 2,0 MM EUDAMED
- Model / Reference
- O100 03 070 2028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680941164089 EUDAMED
- Basic UDI-DI
- B-08680941164089 EUDAMED
- EMDN Code
- P09120301 KIRSCHNER BONE WIRES 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: Orthopaedic bone pin, non-bioabsorbable
Ortimplant by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone pin, non-bioabsorbable.
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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-08680941164089 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017438
Sources (1)
- EUDAMED e23a55ff-cd25-462b-b62b-37383b758809 61 fields · synced Jun 20, 2026