Identity
- Trade Name
- TROLLINO BLUE with 951 Height adjustable push handles EUDAMEDTROLLINO FDA UDI
- Generic Name
- Assistive pushchair FDA UDI
- Device Name
- TROLLINO is an assistive device for children and teens (95 - 140 cm tall) that need a system for mobility during everyday activities, with different levels of functional and postural needs. It allows the positioning of the user with disabilities of various complexity in the most appropriate and functional posture to the different contexts of daily life. The postural options (padded covers, harnesses, belts) allow to give stability to the pelvis, lower limbs, trunk and head, and to take different positions thanks to the reclining of the backrest. It can therefore be also used in medium gravity circumstances, in outdoor environments, for the transport of those users who are not able to maintain their sitting posture, due to severe diseases of the nervous system, of the muscular apparatus or relational sphere. FDA UDI
- Model / Reference
- TROLLI EUDAMED55 EUDAMEDTROLLINO BLUE with 951 Height adjustable push handles FDA UDI
- Description
- TROLLINO is an assistive device for children and teens (95 - 140 cm tall) that need a system for mobility during everyday activities, with different levels of functional and postural needs. It allows the positioning of the user with disabilities of various complexity in the most appropriate and functional posture to the different contexts of daily life. The postural options (padded covers, harnesses, belts) allow to give stability to the pelvis, lower limbs, trunk and head, and to take different positions thanks to the reclining of the backrest. It can therefore be also used in medium gravity circumstances, in outdoor environments, for the transport of those users who are not able to maintain their sitting posture, due to severe diseases of the nervous system, of the muscular apparatus or relational sphere. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715707807 EUDAMEDFDA UDI
- Basic UDI-DI
- 805571570TROLLIPL EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
- GMDN Term
- Assistive pushchair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 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
Category: Assistive pushchair
Trollino by Ormesa Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ormesa Srl
Sources (2)
- FDA UDI b9780334-5b84-4e9c-82ec-ded23d1c13cc 33 fields · synced Aug 1, 2026
- EUDAMED 459f72a1-5ef1-4b41-b876-d6a1b147f4f6 61 fields · synced Aug 1, 2026