Identity
- Trade Name
- Ortho EUDAMED
- Device Name
- Ankle Brace Criss Cross XL EUDAMED
- Model / Reference
- 6222012070732 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06222012070732 EUDAMED
- Basic UDI-DI
- 6222012070732NB EUDAMED
- EMDN Code
- Y061218 HIP-KNEE-ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Ortho 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 | 6222012070732NB | 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 78cb7966-270f-43e6-8c47-df8c559a1b4e 61 fields · synced Jun 19, 2026