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Manual Wheelchair
EUDAMEDClass I (EU MDR)
Ref KY809-46Model ME1 ME2 ME3 ME4 ME5 ME6 ME7 ME8 ME9 ME10 ME11 ME12 ME13 ME14 ME15 ME16 ME17 ME18 ME19 ME20 ME21 ME22 ME23 ME24 ，etc.
Identity
- Device Name
- Manual Wheelchair EUDAMED
- Model / Reference
- ME1 ME2 ME3 ME4 ME5 ME6 ME7 ME8 ME9 ME10 ME11 ME12 ME13 ME14 ME15 ME16 ME17 ME18 ME19 ME20 ME21 ME22 ME23 ME24 ，etc. EUDAMEDKY809-46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975883470179 EUDAMED
- Basic UDI-DI
- 697588347MWheelchairW6 EUDAMED
- EMDN Code
- Y122103 PUSH 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
Manual 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 | 697588347MWheelchairW6 | 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 f1479f39-24ea-40aa-ae86-37bcdb7e6e48 61 fields · synced Jun 18, 2026