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Walker
EUDAMEDFDA UDIClass I (EU MDR)
Ref CA826LModel CA811L, CA811LG, CA811L-Y, CA8115L, CA812L, CA812L-C, CA812LW, CA812LG, CA812LMG, CA812LSG, CA8124LG, CA8125L, CA8126LG, CA8127LG, CA8128L,etc
Identity
- Trade Name
- walker FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- Walker EUDAMED
- Model / Reference
- CA811L, CA811LG, CA811L-Y, CA8115L, CA812L, CA812L-C, CA812LW, CA812LG, CA812LMG, CA812LSG, CA8124LG, CA8125L, CA8126LG, CA8127LG, CA8128L,etc EUDAMEDCA826L EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972223253324 EUDAMEDFDA UDI
- Basic UDI-DI
- 697222325050001KG EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120606 WHEELED WALKER 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
- France 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Walker by Foshan Shunkangda Medical Tech Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697222325050001KG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foshan Shunkangda Medical Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000008483
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED e6cf109c-c199-47de-83e6-ebdd5b377854 61 fields · synced Jun 18, 2026
- FDA UDI 34df9676-1b21-4bfc-a976-326d6dcd8b22 32 fields · synced May 30, 2026