Identity
- Trade Name
- Sana EUDAMED
- Device Name
- SANA GENUNCHIERA L EUDAMED
- Model / Reference
- 6222012099504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06222012099504 EUDAMED
- Basic UDI-DI
- 6222012099504QH EUDAMED
- EMDN Code
- Y061218 HIP-KNEE-ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Sana by Miracle Medical Industries — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6222012099504QH | 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 855a3d5e-a451-4a2e-8a39-0ac5e5960f83 61 fields · synced Jun 18, 2026