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Orti̇mplant
EUDAMEDClass I (EU MDR)
Ref OSI180123Model ORTİMPLANT
by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi
Identity
- Trade Name
- ORTİMPLANT EUDAMED
- Device Name
- REAMER AND AWL 14CM EUDAMED
- Model / Reference
- ORTİMPLANT EUDAMEDOSI180123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683206600261 EUDAMED
- Basic UDI-DI
- 8683206ODRL000017D EUDAMED
- Direct Marketing DI
- 08683206600261 EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Acetabular orthopaedic reamer
Orti̇mplant by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8683206ODRL000017D | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017438
Sources (1)
- EUDAMED b4950f66-c003-46a6-8d0a-079a9d1a92b5 61 fields · synced Jun 20, 2026