Identity
- Trade Name
- HEEL CUSION X LARGE EUDAMED
- Device Name
- Silicare Silicone Heel Cushion EUDAMED
- Model / Reference
- 1710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904044280133 EUDAMED
- Basic UDI-DI
- 890404421710D2 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I 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
Heel Cusion X Large by Dynamic Techno Medicals Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 890404421710D2 | Class I | Active |
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Manufacturer
- Manufacturer
- Dynamic Techno Medicals Pvt Ltd
- EUDAMED SRN
- IN-MF-000017845
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 300a0dc9-79ae-4464-9a75-e21f2e6b3a7e 61 fields · synced Jul 19, 2026