ICB Orthotics
by ICB Medical Distributors Pty Ltd 99 variants
Part of a family of 98 devices: see the family page
Ref ICBHL8S
ICB Orthotics (ICBHL8S) is a Class I device made by ICB Medical Distributors Pty Ltd, registered in EUDAMED on 6 May 2026 (Basic UDI-DI 8420100ICBORTHOTICS2R), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8420100ICBORTHOTICS2R 00842010051128 | Date6 May 2026 | StatusActive |
Official records
- EUDAMED public site 8420100ICBORTHOTICS2R
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- ICB Orthotics
- Model / reference
- ICBHL8S
- Primary DI / UDI-DI
- 00842010051128
- Basic UDI-DI
- 8420100ICBORTHOTICS2R
- EMDN code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Malta
Manufacturer details
- EUDAMED SRN
- AU-MF-000053419
- Authorised representative
- Advena Limited MT-AR-000000234
From the manufacturer
Manufacturer's product page: How to Heat Mould
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