Spex Limited

FDA UDI

Class I (US FDA UDI)

by Spex Limited

Identity

Trade Name: Spex Limited FDA UDI
Generic Name: Wheelchair/chair/stander headrest FDA UDI
Device Name: Stylo 130 Mechanism FDA UDI
Model / Reference: 1274-1232-000 FDA UDI
Description: Stylo 130 Mechanism FDA UDI

Identifiers

Primary DI / UDI-DI: 09420051709690 FDA UDI
FDA Product Code: IMS FDA UDI
GMDN Term: Wheelchair/chair/stander headrest FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3910 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wheelchair/chair/stander headrest

Spex Limited by Spex Limited — 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: Spex Limited

Sources (1)

FDA UDI d3157010-4d50-40d4-a1ea-8d54cab89d3d 34 fields · synced May 30, 2026