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Dr Scholl’s Run Soletta
EUDAMEDClass I (EU MDR)
Ref 9038316 - (9038314)Ref 9038312
Identity
- Trade Name
- Dr Scholl’s Run Soletta EUDAMED
- Device Name
- Dr. Scholl's Insoles EUDAMED
- Model / Reference
- 9038316 - (9038314) EUDAMED9038312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056585804026 EUDAMED05056585804019 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
- 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
Dr Scholl’s Run Soletta by Scholl’s Wellness Company Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 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 (2)
- EUDAMED 9751f078-9ccc-4dc1-a462-db4a2a6fb69b 61 fields · synced Oct 6, 2026
- EUDAMED aa8bcde2-bc4d-4ca6-b8a6-de2c202df198 61 fields · synced May 17, 2026