Identity
- Device Name
- ICB Orthotics EUDAMED
- Model / Reference
- ICBXHL10L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842010051241 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
- Malta 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 |
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Manufacturer
- Manufacturer
- ICB Medical Distributors Pty Ltd
- EUDAMED SRN
- AU-MF-000053419
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED d3c6d320-bfc3-4ac5-a2dd-f4d592485810 61 fields · synced Oct 6, 2026