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Scholl In-Balance Zona Lombare PLANTARE SOLLIEVO DOLORE
EUDAMEDClass I (EU MDR)
Ref 4000133Ref 3144874Ref 4000134
Identity
- Trade Name
- Scholl In-Balance Zona Lombare PLANTARE SOLLIEVO DOLORE EUDAMEDScholl Zona Lombare PLANTARE SOLLIEVO DOLORE EUDAMED
- Device Name
- Scholl In-Balance Orthotics Insoles EUDAMED
- Model / Reference
- 4000133 EUDAMED3144874 EUDAMED4000134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056860821554 EUDAMED08056860821578 EUDAMED08056860821530 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
- Italy 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 Zona Lombare PLANTARE SOLLIEVO DOLORE 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 d217eb97-a80b-49d7-ba5f-990a1be1e1c2 61 fields · synced Oct 6, 2026
- EUDAMED c6234868-4a3b-4644-98e0-46755965564d 61 fields · synced Jul 10, 2026
- EUDAMED 7e83b312-440f-48df-b7f0-e46ef1d75562 61 fields · synced Jul 19, 2026