Trollino

FDA UDI

Class I (US FDA UDI)

by Ormesa Srl

Identity

Trade Name: TROLLINO 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: TROLLINO RED 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: 08055715707180 FDA UDI
FDA Product Code: INM FDA UDI
GMDN Term: Assistive pushchair FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Assistive pushchair

Trollino by Ormesa Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ormesa Srl

Sources (1)

FDA UDI 63dbc671-d389-425c-9a3b-baf2bf4bf84d 33 fields · synced May 31, 2026