Identity
- Trade Name
- Magic Extreme X8 EUDAMED
- Device Name
- Power Wheelchair Magic Mobility EUDAMED
- Model / Reference
- Extreme X8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09356399059695 EUDAMED
- Basic UDI-DI
- 9356399pwcmagicT3 EUDAMED
- Direct Marketing DI
- 09356399059695 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Magic Extreme X8 by Red Milawa Pty Ltd T/A Magic Mobility — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211574 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 9356399pwcmagicT3 | Class I | Active |
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Manufacturer
- Manufacturer
- Red Milawa Pty Ltd T/A Magic Mobility
- EUDAMED SRN
- AU-MF-000034907
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (2)
- EUDAMED 68823f0f-798f-4bbb-84ce-301779e37a38 61 fields · synced Jun 18, 2026
- FDA 510(k) K211574 1 fields · synced May 18, 2026