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ICB Orthotics

by ICB Medical Distributors Pty Ltd 99 variants

Part of a family of 98 devices: see the family page

Ref ICBHL6M

ICB Orthotics (ICBHL6M) 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 European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8420100ICBORTHOTICS2R Basic UDI-DI 00842010051081UDI-DIDate6 May 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
ICB Orthotics
Model / reference
ICBHL6M
Primary DI / UDI-DI
00842010051081
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

Similar devices in this category

Other devices filed under ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS).

Other devices from ICB Medical Distributors Pty Ltd

See all devices from ICB Medical Distributors Pty Ltd →

Properties

Other properties (14, all answered No)