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Heel Elevator - Small/Medium (Shoes Sizes 3 - 8 1/2)
EUDAMEDClass I (EU MDR)
Ref HE-S/MModel HE
by Chaneco Ltd
Identity
- Trade Name
- Heel Elevator - Small/Medium (Shoes Sizes 3 - 8 1/2) EUDAMED
- Device Name
- Heel Elevators EUDAMED
- Model / Reference
- HE EUDAMEDHE-S/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056157605860 EUDAMED
- Basic UDI-DI
- 50561576HeelElevator8G EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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 Elevator - Small/Medium (Shoes Sizes 3 - 8 1/2) by Chaneco 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 | 50561576HeelElevator8G | Class I | Active |
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Manufacturer
- Manufacturer
- Chaneco Ltd
- EUDAMED SRN
- UK-MF-000043937
- Authorised Representative
- UKALIA Limited XI-AR-000024526
Sources (1)
- EUDAMED e8c9ec45-f9ee-44b8-b891-97b52e1ddb25 61 fields · synced Jul 11, 2026