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Electric wheelchairs
EUDAMEDFDA UDIClass I (EU MDR)
Ref DF4110Ref DR4202
by Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
Identity
- Trade Name
- Lerado FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Electric wheelchairs EUDAMED
- Model / Reference
- DF4110 EUDAMEDFDA UDIDR4202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973134780039 EUDAMEDFDA UDI06973134780022 EUDAMED
- Basic UDI-DI
- 697313478PW001JP EUDAMED
- Direct Marketing DI
- 06973134780039 EUDAMED06973134780022 EUDAMED
- 510(k) Number
- K130982 FDA UDI
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Electric wheelchairs by Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697313478PW001JP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000012010
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (3)
- EUDAMED 45f089de-eb2f-460e-bf5d-fcfd251d2fc7 61 fields · synced Jul 9, 2026
- EUDAMED f52037dd-103a-49f3-9cb4-859ca4d913f8 61 fields · synced May 19, 2026
- FDA UDI 0f1c1f38-c12f-42d9-9484-d257b5b207b8 33 fields · synced May 30, 2026