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Powered Wheelchair
EUDAMEDClass I (EU MDR)
Ref DYW-TX-A1(3230)Model ME192 ME193 ME194 ME195 ME196 ME197 ME198 ME199 ME200 ME201 ME202 ME203 ME204 ME205 ME206 ME207 ME208 ME209 ME210 ME211 ME212 ME213 ME214 ME215 ME216 THE159、DYW-TX-A1(3230)
Identity
- Device Name
- Powered Wheelchair EUDAMED
- Model / Reference
- ME192 ME193 ME194 ME195 ME196 ME197 ME198 ME199 ME200 ME201 ME202 ME203 ME204 ME205 ME206 ME207 ME208 ME209 ME210 ME211 ME212 ME213 ME214 ME215 ME216 THE159、DYW-TX-A1(3230) EUDAMEDDYW-TX-A1(3230) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975883470209 EUDAMED
- Basic UDI-DI
- 697588347PWheelchairZ3 EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Wheelchair by Hospital & Homecare Medical Device Co., Ltd. China — 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 | 697588347PWheelchairZ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Hospital & Homecare Medical Device Co., Ltd. China
- EUDAMED SRN
- CN-MF-000032014
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 12af45ea-6b6d-4151-982a-b639560de9f2 61 fields · synced Oct 6, 2026