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ICB Orthotics
EUDAMEDClass I (EU MDR)
Ref 0008MTFRef 0011WHCRef 0026DLRef 0063EZRef 0046DLRef 0014GNCRef 0053DLRef 0014WHRef 0021GNCRef 0016WHCRef 0011DLRef 0024BUCRef 0007MTFRef 0013BURef 0012DLRef 0050DLRef 0023WHCRef 0013WHCRef 0022GNCRef 0052SPRef 0012WHRef 0021WHRef 0021WHCRef 0020MTFRef 0013DLRef 0022WHCRef 0011BUCRef 0026BUCRef 0033HHCRef 0009MTFRef 0017MTFRef 0013BUCRef 0023DLRef 0014WHCRef 0023WHRef 0016DLRef 0022BURef 0021MTFRef 0065EZRef 0022WHRef 0015WHRef 0021MTRef 0050SPRef 0051DLRef 0014BUCRef 0010BUCRef 0016MTFRef 0009MTRef 0042DLRef 0025BURef 0013WH
Identity
- Device Name
- ICB Orthotics EUDAMED
- Model / Reference
- 0008MTF EUDAMED0011WHC EUDAMED0026DL EUDAMED0063EZ EUDAMED0046DL EUDAMED0014GNC EUDAMED0053DL EUDAMED0014WH EUDAMED0021GNC EUDAMED0016WHC EUDAMED0011DL EUDAMED0024BUC EUDAMED0007MTF EUDAMED0013BU EUDAMED0012DL EUDAMED0050DL EUDAMED0023WHC EUDAMED0013WHC EUDAMED0022GNC EUDAMED0052SP EUDAMED0012WH EUDAMED0021WH EUDAMED0021WHC EUDAMED0020MTF EUDAMED0013DL EUDAMED0022WHC EUDAMED0011BUC EUDAMED0026BUC EUDAMED0033HHC EUDAMED0009MTF EUDAMED0017MTF EUDAMED0013BUC EUDAMED0023DL EUDAMED0014WHC EUDAMED0023WH EUDAMED0016DL EUDAMED0022BU EUDAMED0021MTF EUDAMED0065EZ EUDAMED0022WH EUDAMED0015WH EUDAMED0021MT EUDAMED0050SP EUDAMED0051DL EUDAMED0014BUC EUDAMED0010BUC EUDAMED0016MTF EUDAMED0009MT EUDAMED0042DL EUDAMED0025BU EUDAMED0013WH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842010011368 EUDAMED00842010010989 EUDAMED00842010011290 EUDAMED00842010031335 EUDAMED00842010011344 EUDAMED00842010010774 EUDAMED00842010011436 EUDAMED00842010010392 EUDAMED00842010010804 EUDAMED00842010011269 EUDAMED00842010010620 EUDAMED00842010010958 EUDAMED00842010011351 EUDAMED00842010010262 EUDAMED00842010010637 EUDAMED00842010011160 EUDAMED00842010011061 EUDAMED00842010011009 EUDAMED00842010010811 EUDAMED00842010031250 EUDAMED00842010010378 EUDAMED00842010010422 EUDAMED00842010011047 EUDAMED00842010011498 EUDAMED00842010010644 EUDAMED00842010011054 EUDAMED00842010010866 EUDAMED00842010011283 EUDAMED00842010010552 EUDAMED00842010011375 EUDAMED00842010011467 EUDAMED00842010010880 EUDAMED00842010010705 EUDAMED00842010011016 EUDAMED00842010010446 EUDAMED00842010011238 EUDAMED00842010010316 EUDAMED00842010011504 EUDAMED00842010031359 EUDAMED00842010010439 EUDAMED00842010010408 EUDAMED00842010010606 EUDAMED00842010031298 EUDAMED00842010011177 EUDAMED00842010010897 EUDAMED00842010010859 EUDAMED00842010011450 EUDAMED00842010010569 EUDAMED00842010010491 EUDAMED00842010010347 EUDAMED00842010010385 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 EUDAMEDCyprus EUDAMEDBelgium EUDAMEDAustria 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 (51)
- EUDAMED 3abae770-dfad-4790-9a66-6568d8f48ac0 61 fields · synced Oct 7, 2026
- EUDAMED 6e4ddd81-9104-4a6b-bb82-49807683218a 61 fields · synced May 11, 2026
- EUDAMED 8ef53fec-49e0-4c66-bf3a-95fbfe5a7194 61 fields · synced May 11, 2026
- EUDAMED 94cae26e-5c3e-4111-a61f-043c0d97f669 61 fields · synced May 11, 2026
- EUDAMED b7cd289a-7c4b-4884-af1a-b8bbe248bad2 61 fields · synced May 11, 2026
- EUDAMED 10ab07c3-25ff-4043-9a6a-dc85cd586a5d 61 fields · synced May 11, 2026
- EUDAMED a128c0dd-802b-4185-8eea-d4649534a106 61 fields · synced May 16, 2026
- EUDAMED a1ac5201-5ffc-4867-ac52-2d2a96d77e00 61 fields · synced May 16, 2026
- EUDAMED 4fdb0284-4e7f-4ea4-8434-24a2c1ea3edc 61 fields · synced May 16, 2026
- EUDAMED addc19ce-e667-4086-aed7-e53d692c59f9 61 fields · synced May 16, 2026
- EUDAMED ddfdd258-04b3-4224-9ce9-878b6d98430c 61 fields · synced May 16, 2026
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- EUDAMED 1d987c35-7ceb-41ab-8bc0-9b8372e3af4d 61 fields · synced May 16, 2026
- EUDAMED 2e734b14-e6d0-4274-a537-496074db45aa 61 fields · synced May 16, 2026
- EUDAMED 14d29658-13b8-416b-9b00-3fed4a216ca8 61 fields · synced May 17, 2026
- EUDAMED fe622266-bc2c-4788-b5e1-0ef6870fd3dc 61 fields · synced May 17, 2026
- EUDAMED 7017e4e1-4212-4844-b143-9df93d679f06 61 fields · synced May 17, 2026
- EUDAMED 11b56f07-b9d9-4114-a82e-96f06486f3a7 61 fields · synced May 17, 2026
- EUDAMED b06968da-8cd9-4b99-bcbd-a1741b252382 61 fields · synced May 17, 2026
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- EUDAMED 18ebc49f-cbb0-442e-819f-7d5730389b6b 61 fields · synced May 17, 2026
- EUDAMED 86641401-8eb2-4220-a04d-0ca82ffc0770 61 fields · synced May 17, 2026
- EUDAMED 18292c52-d92e-41d5-8932-b3894ab75b48 61 fields · synced May 17, 2026
- EUDAMED 1492a97a-efcb-4c4f-b990-2de5798b3e71 61 fields · synced May 17, 2026
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- EUDAMED 86068800-465d-439d-9951-7b7c1227d705 61 fields · synced May 17, 2026
- EUDAMED 891fd9de-7b3a-47cb-b341-d1431e667e9a 61 fields · synced May 17, 2026
- EUDAMED 7193383d-a7d7-4432-8376-68177775419d 61 fields · synced May 17, 2026
- EUDAMED baaf4cfa-7d21-472d-8ac6-d8e64bf3ba02 61 fields · synced May 17, 2026
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- EUDAMED e148fa50-04d3-46d8-aef4-c6ca8e6104a0 61 fields · synced May 17, 2026
- EUDAMED 5aca93e3-7abc-4fe7-8499-94e075173f75 61 fields · synced May 17, 2026
- EUDAMED 64957fef-c357-4457-8d7e-d1a71a457a1c 61 fields · synced May 18, 2026
- EUDAMED 66e0eace-e65a-4848-b0f0-9f9301073bc2 61 fields · synced May 18, 2026
- EUDAMED 4244196d-1df4-40c4-84b1-3da161bd706d 61 fields · synced May 18, 2026
- EUDAMED 05a2b4ee-d09c-4d7d-8c9a-6a2abaaa8d7d 61 fields · synced May 18, 2026
- EUDAMED 8306613b-3b8a-4546-ade7-382b02f8c6c9 61 fields · synced May 18, 2026
- EUDAMED 3a62d107-2d96-4d4e-a841-11d6a63ba3a2 61 fields · synced May 18, 2026
- EUDAMED 859e6b38-27c1-4487-82c9-ca85f508613e 61 fields · synced May 18, 2026
- EUDAMED 3135ef35-345f-407a-ad20-e8ed24fd4c79 61 fields · synced May 18, 2026
- EUDAMED e28c211d-61cf-460a-af8b-f173eeb2048c 61 fields · synced May 18, 2026
- EUDAMED e0a35edd-6343-499b-9b4d-437071e00b41 61 fields · synced May 18, 2026