gudid
Primary ID: BIRILLO-2
BIRILLO (UDI BIRILLO-2)
Manufactured by ORMESA SRL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BIRILLO - Primary ID BIRILLO-2
Device Regulatory Overview
The BIRILLO (Model/Catalog Number: BIRILLO-2) is a medical device manufactured by ORMESA SRL. This product is indexed under FDA Product Code / Category Classification ITJ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- BIRILLO-2
- Product Code / EMDN
- ITJ
- Device Name
- 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.
- Database Sync Date
- 2026-08-09 09:04:30
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of BIRILLO?
The registered manufacturer of record for BIRILLO is ORMESA SRL.
What is the Primary UDI-DI identifier for BIRILLO?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BIRILLO-2.
What classification code is assigned to this device?
This device is registered under product classification code ITJ.
Similar Classification Devices (ITJ)
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