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Abena

FDA UDI

Class I (US FDA UDI)

by Abena North America, Inc.

Identity

Trade Name
Abena FDA UDI
Generic Name
Adult nappy FDA UDI
Device Name
Abri-Form Premium Junior Incontinence holds 51 fluid ounces/1500 ml, for individuals with waist and hip measurements from 19.5 to 24". Generally it is classified as a XS size. FDA UDI
Model / Reference
43050 FDA UDI
Description
Abri-Form Premium Junior Incontinence holds 51 fluid ounces/1500 ml, for individuals with waist and hip measurements from 19.5 to 24". Generally it is classified as a XS size. FDA UDI

Identifiers

Primary DI / UDI-DI
05703538199776 FDA UDI
FDA Product Code
EYQ FDA UDI
GMDN Term
Adult nappy FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Adult nappy

Abena by Abena North America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Adult nappy.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 583ea2ed-9c46-4484-b941-b6a394299833 36 fields · synced Jun 6, 2026