Identity
- Trade Name
- IB-ER EUDAMED
- Device Name
- Silicone Gel Liners EUDAMED
- Model / Reference
- KM-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680757257159 EUDAMED
- Basic UDI-DI
- 8680757250004AJ EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - 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 | 8680757250004AJ | Class I | Active |
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Manufacturer
- Manufacturer
- Ib-Er Makina Anonim Sirketi
- EUDAMED SRN
- TR-MF-000045117
Sources (1)
- EUDAMED a3690723-ec83-405d-8d23-ca223d75d294 61 fields · synced Jun 18, 2026