Identity
- Trade Name
- Dr. Scholl's Heel & Arch Orthotic Women’s EUDAMED
- Device Name
- Dr. Scholl's Insoles EUDAMED
- Model / Reference
- 9090353 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056585805993 EUDAMED
- Basic UDI-DI
- 50565858MDRO34NT 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
Dr. Scholl's Heel & Arch Orthotic Women’s by Scholl’s Wellness Company Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 50565858MDRO34NT | Class I | Active |
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Manufacturer
- Manufacturer
- Scholl’s Wellness Company Limited
- EUDAMED SRN
- GB-MF-000034304
- Authorised Representative
- Scholl's Welness company B.V. NL-AR-000032949
Sources (1)
- EUDAMED f30290d2-00c0-48e6-a049-7a7915cb531f 61 fields · synced Jun 19, 2026