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Silicon Heel Cushion - With Softness Adjustable Pads-L
EUDAMEDClass I (EU MDR)
Ref ARF03Y-LRG
Identity
- Trade Name
- SILICON HEEL CUSHION - WITH SOFTNESS ADJUSTABLE PADS-L EUDAMED
- Device Name
- FOOT CARE EUDAMED
- Model / Reference
- ARF03Y-LRG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853110150 EUDAMED
- Basic UDI-DI
- 868085310FOOTM2 EUDAMED
- Direct Marketing DI
- 08680853110150 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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: Orthotic insole, prefabricated, non-antimicrobial
Silicon Heel Cushion - With Softness Adjustable Pads-L by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇ — Class I — MDR — listed in EUDAMED
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 868085310FOOTM2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
- EUDAMED SRN
- TR-MF-000030874
Sources (1)
- EUDAMED 2ab1db50-1f76-4e7f-a160-0f8c92f0a2ae 61 fields · synced Oct 6, 2026