Device Explorer · FDA GUDID · GMDN 11239

Adult nappy

A disposable undergarment (a nappy or diaper) composed of absorbent material and worn between the legs used to collect urine and faeces from an incontinent adult patient. This is a single-use device.

US‑registered devices132in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile2%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Abena North America, Inc8061%
Resilient Medical Solutions, Llc1310%
Europrosan Spa97%
The Gilbert Group Llc86%
Customed Inc54%
Simple Diagnostics Inc32%
Aloha Home Health Care Services Llc32%
Zhangzhou Win Share Co.,Ltd.32%

Top labelers

CompanyDevicesShare
Abena North America, Inc8061%
Resilient Medical Solutions, Llc1310%
Europrosan Spa97%
The Gilbert Group Llc86%
Customed Inc54%
Simple Diagnostics Inc32%
Aloha Home Health Care Services Llc32%
Zhangzhou Win Share Co.,Ltd.32%
Twin Med, Llc32%
Essity Hygiene And Health Ab22%
Xiantao Topmed Nonwoven Protective Products Co.,Ltd11%
Changzhou Hongtai Paper Film Co.,Ltd.11%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TopmedHTMegaMaxAbenaClever ChoiceCheekZBrightCareBrightCare MedsoftResilient Medical SolutionsTENACuteleafProCureCUSTOMEDFLUFSAN

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EYQGarment, Protective, For Incontinence159
KPNALARM, CONDITIONED RESPONSE ENURESIS2
OHOFirst Aid Kit Without Drug1
NACDressing, Wound, Hydrophilic1

GMDN & GCC registration

  • GMDN code 11239 · non‑implantable
  • Single‑use 100% · sterile 2% · Rx‑only 0% · OTC 12%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Circumference (Inch) · 3Weight (Kilogram) · 1

Use these as the dimensions to specify in a tender line.

How many adult nappy products are registered in the US?

132 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Adult nappy", from 13 companies. The largest labeler is Abena North America, Inc with 61% of records.

Which FDA product codes apply?

EYQ (Garment, Protective, For Incontinence), KPN (ALARM, CONDITIONED RESPONSE ENURESIS), OHO (First Aid Kit Without Drug), NAC (Dressing, Wound, Hydrophilic)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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