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Device Explorer · FDA GUDID · GMDN 45605

Single-administration urethral catheterization kit, single-use

A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to

US‑registered devices522in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile97%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Wellspect Ab14428%
Medical Technologies Of Georgia, Inc.12524%
Coloplast A/S6813%
Hr Pharmaceuticals Inc.6112%
Hollister Incorporated347%
United Urologics Inc306%
Compactcath, Inc.265%
Convatec, Purchasing Department153%

Top labelers

CompanyDevicesShare
Wellspect Ab14428%
Medical Technologies Of Georgia, Inc.12524%
Coloplast A/S6813%
Hr Pharmaceuticals Inc.6112%
Hollister Incorporated347%
United Urologics Inc306%
Compactcath, Inc.265%
Convatec, Purchasing Department153%
Medline Industries, Inc.61%
Apollo Medical Products Corp.41%
Avanos Medical, Inc.41%
Geri-Gentle Corporation41%

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

Brand names on the register (sample)

LoFric® Origo™LoFric OrigoGentleCath Hydrophilic KitSimPro™ SetLoFric® Primo™LoFric® Hydro-Kit™SimPro™ NowGentleCath HydrophilicLoFric® Sense™SpeediCath Compact SetLuja SetSpeediCath Flex SetSpeediCath Compact MaleSelf-Cath Closed SystemSureCath SetSpeediCath Standard

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

FDA product codes

CodeNameDevices
EZDCATHETER, STRAIGHT288
EZDCatheter, straight157
KODCatheter, Urological123
KODCATHETER, UROLOGICAL62
OHRCatheter care tray37
GBMCatheter, Urethral36

GMDN & GCC registration

  • GMDN code 45605 · non‑implantable
  • Single‑use 100% · sterile 97% · Rx‑only 91% · OTC 6%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Catheter Gauge (French) · 704Length (Inch) · 447Catheter Working Length (Centimeter) · 81Catheter Working Length (Inch) · 73Outer Diameter (Millimeter) · 17Length (Centimeter) · 17

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

How many single-administration urethral catheterization kit, single-use products are registered in the US?

522 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Single-administration urethral catheterization kit, single-use", from 13 companies. The largest labeler is Wellspect Ab with 28% of records.

Which FDA product codes apply?

EZD (CATHETER, STRAIGHT), EZD (Catheter, straight), KOD (Catheter, Urological), KOD (CATHETER, UROLOGICAL)

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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