Identity
- Trade Name
- U-shape Heel Spur Pads EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 5464-S EUDAMED5464-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840270625905 EUDAMED00840270625912 EUDAMED
- Basic UDI-DI
- 08402706CL1074X EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
U-shape Heel Spur Pads by OPPO Medical Inc. — 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 | 08402706CL1074X | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Inc.
- EUDAMED SRN
- US-MF-000005202
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 2b2e8956-7f68-43e0-af71-7ff6e5f61270 61 fields · synced Jul 27, 2026
- EUDAMED 583489c5-b78c-4398-93ec-0b4728d0a1e2 61 fields · synced May 19, 2026