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Device Explorer · FDA GUDID · GMDN 64438

Compression/pressure tubular garment

A device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thromb

US‑registered devices1,548in commercial distribution
Companies10labelers on GUDID
Single‑use14%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Calzificio Pinelli Srl1,09471%
Sigvaris Inc21614%
Ideavillage Products Corp1057%
Vive Health Llc946%
Sun Scientific, Inc.161%
Alimed, Inc.121%
Ceeport Inc.40%
Ningbo Kehu Medical Technology Co.,Ltd.30%

Top labelers

CompanyDevicesShare
Calzificio Pinelli Srl1,09471%
Sigvaris Inc21614%
Ideavillage Products Corp1057%
Vive Health Llc946%
Sun Scientific, Inc.161%
Alimed, Inc.121%
Ceeport Inc.40%
Ningbo Kehu Medical Technology Co.,Ltd.30%
Indaco Srl20%
Manamed, Inc.20%

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

Brand names on the register (sample)

OPTIFORM TOE CAPS / SILK LINING / SILK POCKET CCOPTIFORM TOE CAPS / SILK LINING CCL2OPTIFORM TOE CAPS / SILK POCKET CCL2OPTIFORM TOE CAPS / SILK LINING / SILK POCKET CCOPTIFORM TOE CAPS / SILK LINING CCL1OPTIFORM TOE CAPS / SILK POCKET CCL1OPTIFORM TOE CAPS CCL2OPTIFORM TOE CAPS CCL1Optiform FeelOptiform HoldOptiform FlexM-Brace AirSunWrap Radial Artery Arm WrapSunWrap Mini 12 Arm Wrap Extra LargeSunWrap Mini 10 Arm Wrap LargeSunWrap Mini 6 Arm Wrap Small

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

FDA product codes

CodeNameDevices
FQLStocking, Medical Support (For General Medical Purposes)915
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Le316
MDRBinder, Medical, Therapeutic148
ITQJoint, Knee, External Brace54
IRDJoint, Elbow, External Limb Component, Mechanical21
MHWDressing, Compression19

GMDN & GCC registration

  • GMDN code 64438 · non‑implantable
  • Single‑use 14% · sterile 0% · Rx‑only 1% · OTC 79%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many compression/pressure tubular garment products are registered in the US?

1,548 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Compression/pressure tubular garment", from 10 companies. The largest labeler is Calzificio Pinelli Srl with 71% of records.

Which FDA product codes apply?

FQL (Stocking, Medical Support (For General Medical Purposes)), DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Le), MDR (Binder, Medical, Therapeutic), ITQ (Joint, Knee, External Brace)

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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