Identity
- Trade Name
- Rollator EUDAMEDLCJ FDA UDI
- Generic Name
- Walking chair, foldable FDA UDI
- Device Name
- Rollator EUDAMED
- Model / Reference
- LCMR004B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975372290196 EUDAMEDFDA UDI
- Basic UDI-DI
- 697537229LCMR004B8H EUDAMED
- Direct Marketing DI
- 06975372290196 EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
- GMDN Term
- Walking chair, foldable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3825 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Rollator by Changzhou Langcheng Intelligent Technology 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 | 697537229LCMR004B8H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000028091
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 96bb9da8-cba0-48d9-b27c-31b87a6d5912 61 fields · synced Jun 18, 2026
- FDA UDI 3f714b76-387f-47b7-97e6-aa2110d21a45 32 fields · synced May 30, 2026