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Knitted Ankle Support-Malleolar-S
EUDAMEDClass I (EU MDR)
Ref ARA9401-SMLRef ARA9400-SML
Identity
- Trade Name
- KNITTED ANKLE SUPPORT-MALLEOLAR-S EUDAMEDKNITTED ANKLE SUPPORT -BASIC-S EUDAMED
- Device Name
- ARM'O KNIT EUDAMED
- Model / Reference
- ARA9401-SML EUDAMEDARA9400-SML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853107495 EUDAMED08680853107440 EUDAMED
- Basic UDI-DI
- 868085310KNITME EUDAMED
- Direct Marketing DI
- 08680853107495 EUDAMED08680853107440 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Knitted Ankle Support-Malleolar-S by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇ — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 | 868085310KNITME | Class I | Active |
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Manufacturer
- Manufacturer
- Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
- EUDAMED SRN
- TR-MF-000030874
Sources (2)
- EUDAMED e4db2260-4906-4c1c-9333-3f28cc5add35 61 fields · synced Oct 6, 2026
- EUDAMED bdd50a69-f473-4655-97ba-37eeadf6fc1e 61 fields · synced May 18, 2026