Identity
- Trade Name
- IB-ER EUDAMED
- Device Name
- Orthotic Components EUDAMED
- Model / Reference
- OKJ140-10-20R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680757253847 EUDAMED
- Basic UDI-DI
- 8680757250010AD EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Ib-Er by Ib-Er Makina Anonim Sirketi — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 8680757250010AD | Class I | Active |
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Manufacturer
- Manufacturer
- Ib-Er Makina Anonim Sirketi
- EUDAMED SRN
- TR-MF-000045117
Sources (1)
- EUDAMED f00064da-a1da-4f72-b516-a7710d169111 61 fields · synced Jun 18, 2026