Consulting Wallah › Device Explorer › Wound care & sutures › Peristomal/periwound dressing
Device Explorer · FDA GUDID · GMDN 46207

Peristomal/periwound dressing

A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is

US‑registered devices99in commercial distribution
Companies10labelers on GUDID
Single‑use92%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Hollister Incorporated3636%
Coloplast A/S3030%
O&M Halyard, Inc.1111%
Cofoe Medical Technology Co.,Ltd55%
Shaoxing Haoshide Medical Products Co., Ltd.44%
Safe N' Simple Llc44%
T.G. Eakin Limited44%
Hr Pharmaceuticals Inc.22%

Top labelers

CompanyDevicesShare
Hollister Incorporated3636%
Coloplast A/S3030%
O&M Halyard, Inc.1111%
Cofoe Medical Technology Co.,Ltd55%
Shaoxing Haoshide Medical Products Co., Ltd.44%
Safe N' Simple Llc44%
T.G. Eakin Limited44%
Hr Pharmaceuticals Inc.22%
Convatec, Purchasing Department22%
Zhende Medical Co., Ltd.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

cofoeBynexBravaColoplastVitusSafe N SimpleSTOMAHESIVEAdaptCeraPlusAdapt CeraRingHalyardEakin

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

FDA product codes

CodeNameDevices
EXBCOLLECTOR, OSTOMY30
EXEPROTECTOR, OSTOMY25
EXEProtector, ostomy16
EXEProtector, Ostomy14
EZSAppliance, colostomy, disposable9
EZRCement, Stomal Appliance, Ostomy7

GMDN & GCC registration

  • GMDN code 46207 · non‑implantable
  • Single‑use 92% · sterile 0% · Rx‑only 0% · OTC 72%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 28Outer Diameter (Millimeter) · 26Lumen/Inner Diameter (Millimeter) · 22Height (Millimeter) · 9Outer Diameter (Inch) · 6Weight (Gram) · 1

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

No closely related category with 50+ devices.

How many peristomal/periwound dressing products are registered in the US?

99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Peristomal/periwound dressing", from 10 companies. The largest labeler is Hollister Incorporated with 36% of records.

Which FDA product codes apply?

EXB (COLLECTOR, OSTOMY), EXE (PROTECTOR, OSTOMY), EXE (Protector, ostomy), EXE (Protector, Ostomy)

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.

How do I get quotes?

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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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