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Walking Devices, Two-Handed Operation
EUDAMEDFDA UDIClass I (EU MDR)
Ref RU4038
by Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
Identity
- Trade Name
- Lerado FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- Walking Devices, Two-Handed Operation EUDAMED
- Model / Reference
- RU4038 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973134780183 EUDAMEDFDA UDI
- Basic UDI-DI
- 697313478AW001DJ EUDAMED
- Direct Marketing DI
- 06973134780183 EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120699 WALKING DEVICES, TWO-HANDED OPERATION - OTHER EUDAMED
- GMDN Term
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3825 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Walking Devices, Two-Handed Operation 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 | 697313478AW001DJ | 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 (2)
- EUDAMED fbc1cf1d-c0db-4ec5-b36d-0ab5d03eb6e4 61 fields · synced Jul 13, 2026
- FDA UDI 5f7c421b-9c4a-4182-a60f-890dec28f0ef 32 fields · synced May 26, 2026