Identity
- Device Name
- ICB Orthotics EUDAMED
- Model / Reference
- 0014BU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842010010279 EUDAMED
- Basic UDI-DI
- 8420100ICBORTHOTICS2R EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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
ICB Orthotics by ICB Medical Distributors Pty Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: How to Heat Mould
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 | 8420100ICBORTHOTICS2R | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ICB Medical Distributors Pty Ltd
- EUDAMED SRN
- AU-MF-000053419
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 688217cd-36de-4a51-97e8-7c9bad5b0961 61 fields · synced Oct 5, 2026