Identity
- Trade Name
- DYNAMICO-5 EUDAMEDDYNAMICO FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, non-foldable FDA UDI
- Device Name
- DYNAMICO EUDAMEDWalking frame intended to provide support and safety to those subjects with reduced functional capacity of maintaining the upright position and walking independently; subjects with disabilities and impaired functional residual capacity or even semi-self-sufficient elderly subjects who must be protected during walking. FDA UDI
- Model / Reference
- DYNAMICO EUDAMED31 EUDAMEDDYNAMICO-5 FDA UDI
- Description
- Walking frame intended to provide support and safety to those subjects with reduced functional capacity of maintaining the upright position and walking independently; subjects with disabilities and impaired functional residual capacity or even semi-self-sufficient elderly subjects who must be protected during walking. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715700846 EUDAMEDFDA UDI
- Basic UDI-DI
- 805571570DYNAMICO6Z EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120612 WALKING TROLLEYS 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
- Italy 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dynamico-5 by ORMESA S.r.l. — 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 | 805571570DYNAMICO6Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ORMESA S.r.l.
- EUDAMED SRN
- IT-MF-000034824
Sources (2)
- EUDAMED 897dfdda-bbf2-4879-a8dc-53488a53ea91 61 fields · synced Jul 9, 2026
- FDA UDI abc84225-52da-43fa-8828-40b4ddbfcd92 33 fields · synced May 30, 2026