Identity
- Trade Name
- BIRILLO-4 EUDAMEDBIRILLO FDA UDI
- Generic Name
- Walking chair, non-foldable FDA UDI
- Device Name
- BIRILLO EUDAMEDWalking fram from a seated position, intended for all those children from 70 to 140 cm height, with functional deficits who need containment a pelvis level (in particular) and trunk level, through the classic “Bobath angle” and that, through the use of "stepping" made possible by the presence of the wheels under the seat, are able to move into the surrounding environment and explore it, becoming a significant stimulus towards greater autonomy. To use the walker, the user needs sufficient strength in the upper and lower limbs, Ability to transfer the load from one limb to another, Head and trunk control, Minimum flexion of the elbows 15-20°, 90° hip flexion. FDA UDI
- Model / Reference
- BIRILLO EUDAMED32 EUDAMEDBIRILLO-4 FDA UDI
- Description
- Walking fram from a seated position, intended for all those children from 70 to 140 cm height, with functional deficits who need containment a pelvis level (in particular) and trunk level, through the classic “Bobath angle” and that, through the use of "stepping" made possible by the presence of the wheels under the seat, are able to move into the surrounding environment and explore it, becoming a significant stimulus towards greater autonomy. To use the walker, the user needs sufficient strength in the upper and lower limbs, Ability to transfer the load from one limb to another, Head and trunk control, Minimum flexion of the elbows 15-20°, 90° hip flexion. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715701201 EUDAMEDFDA UDI
- Basic UDI-DI
- 805571570BIRILLONG EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120609 WALKING FRAMES WITH CHAIR, 4 WHEELS EUDAMED
- GMDN Term
- Walking chair, 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
Birillo-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 | 805571570BIRILLONG | 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 65d339e4-ad35-4481-85ee-df92fc12749c 61 fields · synced Jul 19, 2026
- FDA UDI 8552b709-dcbe-43db-87e8-ff778d9fbcb5 33 fields · synced May 30, 2026