Identity
- Trade Name
- Scholl In-Balance FASCIITE PLANTAIRE SEMELLESANTI-DOULEUR EUDAMED
- Device Name
- Scholl In-Balance Orthotics Insoles EUDAMED
- Model / Reference
- 4000024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056585800271 EUDAMED
- Basic UDI-DI
- 50565858MDR027J8 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Scholl In-Balance Orthotics Insoles by Scholl’s Wellness Company Limited — 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 | 50565858MDR027J8 | 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 (2)
- EUDAMED 337e5f21-3cd3-4794-8cfc-ba8847d908b4 61 fields · synced Jun 19, 2026
- EUDAMED b53b2b40-23bb-420e-8b16-69ad837e1f1b 61 fields · synced Jun 19, 2026