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Spex Limited

FDA UDI

Class I (US FDA UDI)

by Spex Limited

Identity

Trade Name
Spex Limited FDA UDI
Generic Name
Wheelchair seat cushion FDA UDI
Device Name
Spare cover, user matched, Spex cushion - Bumblebee Yellow FDA UDI
Model / Reference
1125-2949-600_044 FDA UDI
Description
Spare cover, user matched, Spex cushion - Bumblebee Yellow FDA UDI

Identifiers

Primary DI / UDI-DI
09420051711143 FDA UDI
FDA Product Code
IMP FDA UDI
GMDN Term
Wheelchair seat cushion FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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: Wheelchair seat cushion

Spex Limited by Spex Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wheelchair seat cushion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spex Limited

Sources (1)

  • FDA UDI c5ebb1de-0572-4787-84bb-628d192c851b 34 fields · synced May 30, 2026