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Grillo Large Post. Pa Ibri(3-4)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 46Model GRILLO GAIT TRAINER
Identity
- Trade Name
- GRILLO LARGE POST. PA IBRI(3-4) EUDAMEDGRILLO FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- GRILLO EUDAMEDPostural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and setting the gait, where the residual of functional capacity allows it, and for whom the gait trainer can be a stimulus to improve one's ability to discover the space around oneself and the environment, to perceive depth, to stimulate proactivity, to improve social interaction. The great versatility of the product makes it usable for people with minimal to severe impairments of functional capacity. FDA UDI
- Model / Reference
- GRILLO GAIT TRAINER EUDAMED46 EUDAMEDGRILLO LARGE POST. PA IBRI(3-4) FDA UDI
- Description
- Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and setting the gait, where the residual of functional capacity allows it, and for whom the gait trainer can be a stimulus to improve one's ability to discover the space around oneself and the environment, to perceive depth, to stimulate proactivity, to improve social interaction. The great versatility of the product makes it usable for people with minimal to severe impairments of functional capacity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08054040402685 EUDAMEDFDA UDI
- Basic UDI-DI
- 805571570GRILLOHD EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y050201 STANDING SUPPORT GAIT TRAINERS 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
- 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
Grillo Large Post. Pa Ibri(3-4) 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 | 805571570GRILLOHD | 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 236c262e-5237-4779-ac35-03097a32c3a6 61 fields · synced Jun 19, 2026
- FDA UDI 242d5a8c-4f17-4e69-b0fd-d0460e051dfe 33 fields · synced May 30, 2026