Identity
- Device Name
- Electric wheelchair EUDAMED
- Model / Reference
- NA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972952320011 EUDAMED06972952320014 EUDAMED06972952320021 EUDAMED
- Basic UDI-DI
- 697295232ew8F EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I 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
Electric wheelchair by Changshu City Hongyi Equipment Technology Co., Ltd. — 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 | 697295232ew8F | Class I | Active |
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Manufacturer
- Manufacturer
- Changshu City Hongyi Equipment Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039004
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 384be2fd-6b0d-4881-b5a0-ecc7db548104 61 fields · synced Oct 6, 2026
- EUDAMED aa5a74fe-f8c7-49c3-b858-b65272cf9e16 61 fields · synced May 17, 2026
- EUDAMED 3925329e-af93-4180-8f95-9b92f8d0aa76 61 fields · synced May 18, 2026