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Scholl In-Balance Orthotics Insoles
EUDAMEDClass I (EU MDR)
Ref 4000021Ref 4000008
Identity
- Trade Name
- Scholl In-Balance Plantar Fasciitis SMERTELINDRENDE INDLÆGSSÅL EUDAMED
- Device Name
- Scholl In-Balance Orthotics Insoles EUDAMED
- Model / Reference
- 4000021 EUDAMED4000008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056585800240 EUDAMED05056585800110 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
- Denmark EUDAMEDGreece 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 (3)
- EUDAMED 8974069b-0d0f-4ebe-ae19-5d901b964054 61 fields · synced Oct 6, 2026
- EUDAMED 02d0d3ea-8da8-4633-b5f5-67fbcbc21cbb 61 fields · synced May 16, 2026
- EUDAMED efa1c599-3661-4fd3-864e-8f37555a949c 61 fields · synced Jul 17, 2026