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Malleo Pro Activ
EUDAMEDClass I (EU MDR)
Ref 23680220500102Ref 23680220300301Ref 23680220300101Ref 23680220300102Ref 23680220500301Ref 23680220100101Ref 23680220400102Ref 23680220400302Ref 23680220500302Ref 23680220300302
by Thuasne
Identity
- Trade Name
- Malleo Pro Activ EUDAMED
- Device Name
- Malleo Pro Activ EUDAMED
- Model / Reference
- 23680220500102 EUDAMED23680220300301 EUDAMED23680220300101 EUDAMED23680220300102 EUDAMED23680220500301 EUDAMED23680220100101 EUDAMED23680220400102 EUDAMED23680220400302 EUDAMED23680220500302 EUDAMED23680220300302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03111790236573 EUDAMED03111790236504 EUDAMED03111790236481 EUDAMED03111790236498 EUDAMED03111790236580 EUDAMED03111790236405 EUDAMED03111790236535 EUDAMED03111790236559 EUDAMED03111790236597 EUDAMED03111790236511 EUDAMED
- Basic UDI-DI
- 311179FR0014CEK EUDAMED
- Direct Marketing DI
- 03111790236573 EUDAMED03111790236504 EUDAMED03111790236481 EUDAMED03111790236498 EUDAMED03111790236580 EUDAMED03111790236405 EUDAMED03111790236535 EUDAMED03111790236559 EUDAMED03111790236597 EUDAMED03111790236511 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Ankle/foot orthosis
Malleo Pro Activ by Thuasne — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 311179FR0014CEK | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thuasne
- EUDAMED SRN
- FR-MF-000001201
Sources (11)
- EUDAMED ebf13919-80b3-4429-8463-ecc07aa0b717 61 fields · synced Sep 30, 2026
- EUDAMED ee337d05-c550-4978-86e3-5b851f408272 61 fields · synced May 11, 2026
- EUDAMED 07bbcb16-6a29-4d39-a14e-8e728ab7feb7 61 fields · synced May 11, 2026
- EUDAMED ba3c2c5a-c97a-48be-adfe-8a067a16fafb 61 fields · synced May 16, 2026
- EUDAMED 2d4cb0d0-34cb-4ee8-af52-9e6c5ac2a8b9 61 fields · synced May 17, 2026
- EUDAMED 74e72f5a-e783-467c-9dd5-6f3b4d906c66 61 fields · synced May 17, 2026
- EUDAMED 2f83d95f-3fac-47f6-a844-39644c24d18f 61 fields · synced May 17, 2026
- EUDAMED 924725ee-ceb0-40fe-b6e4-552ca7c34bd2 61 fields · synced May 17, 2026
- EUDAMED 937699d4-4671-47fb-ad0c-30cc23fd9480 61 fields · synced May 19, 2026
- EUDAMED d7af360d-4652-48fb-b2c1-9bc4dc79209d 61 fields · synced May 19, 2026
- EUDAMED a9e39384-b4e2-4f41-9afb-1196f106547b 61 fields · synced Jul 8, 2026