Identity
- Trade Name
- Miracle EUDAMED
- Device Name
- Kids Flat Foot Mats M EUDAMED
- Model / Reference
- 6222012005208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06222012005208 EUDAMED
- Basic UDI-DI
- 6222012005208LB EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I 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
Miracle by Miracle Medical Industries — 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 | 6222012005208LB | Class I | Active |
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Manufacturer
- Manufacturer
- Miracle Medical Industries
- EUDAMED SRN
- EG-MF-000032514
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6d19a7d8-1336-4ea1-a7ca-8f5fb0f03775 61 fields · synced Oct 5, 2026