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Powered Wheelchairs
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref MAMBO 201Model Powered Wheelchairs
Identity
- Device Name
- Powered Wheelchairs EUDAMED
- Model / Reference
- Powered Wheelchairs EUDAMEDMAMBO 201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08936122613014 EUDAMED
- Basic UDI-DI
- 893612261WT3860GQ EUDAMED
- Direct Marketing DI
- 08936122613014 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Powered Wheelchairs by WU’S Tech (Vietnam) Co., Ltd. — 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 | K181163 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 893612261WT3860GQ | Class I | Active |
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Manufacturer
- Manufacturer
- WU’S Tech (Vietnam) Co., Ltd.
- EUDAMED SRN
- VN-MF-000011591
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (2)
- EUDAMED 9146576b-fa46-4f32-930b-4cabe700c4a9 61 fields · synced Jun 19, 2026
- FDA 510(k) K181163 1 fields · synced May 18, 2026