Identity
- Trade Name
- MJM INTERNATIONAL CORP FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, non-foldable FDA UDI
- Device Name
- WALKERS EUDAMEDWALKERS TO PROVIDE / PROMOTE PATIENT INDEPENDENCE; ALLOWS RESIDENTS TO AMBULATE SAFELY IN HEALTHCARE FACILITIES AND / OR PRIVATE HOMES FDA UDI
- Model / Reference
- 400 SERIES EUDAMEDWALKER FDA UDI
- Description
- WALKERS TO PROVIDE / PROMOTE PATIENT INDEPENDENCE; ALLOWS RESIDENTS TO AMBULATE SAFELY IN HEALTHCARE FACILITIES AND / OR PRIVATE HOMES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849229001371 EUDAMEDFDA UDI
- Basic UDI-DI
- 08492290849229001371XY EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Handgrip disability-assistive walker, non-powered, non-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
Walkers by MJM International Corporation — 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 | 08492290849229001371XY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MJM International Corporation
- EUDAMED SRN
- US-MF-000028557
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a1bfab0a-4707-4263-9043-c0a058a76018 61 fields · synced Jun 9, 2026
- FDA UDI ecb8dfa6-9b6e-4604-b4d9-44168c377b2a 33 fields · synced May 30, 2026