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Device Explorer · FDA GUDID · GMDN 14307

Urodynamic measurement system

An assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstr

US‑registered devices172in commercial distribution
Companies9labelers on GUDID
Single‑use27%of device records
Sterile23%labelled sterile
Prescription38%Rx‑only share
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Share of device records

Medical Measurement Systems B.V.5532%
Laborie Medical Technologies Canada Ulc4426%
Mediplus Ltd3219%
Coopersurgical, Inc.138%
Medkonsult Medical Technology S.R.O.127%
Cook Incorporated63%
Spes Medica Spa63%
Laborie Medical Technologies Corp.32%

Top labelers

CompanyDevicesShare
Medical Measurement Systems B.V.5532%
Laborie Medical Technologies Canada Ulc4426%
Mediplus Ltd3219%
Coopersurgical, Inc.138%
Medkonsult Medical Technology S.R.O.127%
Cook Incorporated63%
Spes Medica Spa63%
Laborie Medical Technologies Corp.32%
Neurosoft, Ooo11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MediplusRivusLumax TS ProInfusion TransducerUroflow TransducerHand Held RemoteLumax™ TS ProCookDewanNXT Go Pump HubNXT Go Infusion HookUPP Puller NXTPIM NXT for FluidPIM NXT for TDOCNXT Pro Docking Station with PumpRemote Control NXT

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

FDA product codes

CodeNameDevices
FENDEVICE, CYSTOMETRIC, HYDRAULIC75
KGZACCESSORIES, CATHETER32
FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)32
FENDevice, Cystometric, Hydraulic28
EXYUroflowmeter9
FAPCYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE7

GMDN & GCC registration

  • GMDN code 14307 · non‑implantable
  • Single‑use 27% · sterile 23% · Rx‑only 38% · OTC 0%
  • 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) · 56Length (Centimeter) · 39

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

How many urodynamic measurement system products are registered in the US?

172 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urodynamic measurement system", from 9 companies. The largest labeler is Medical Measurement Systems B.V. with 32% of records.

Which FDA product codes apply?

FEN (DEVICE, CYSTOMETRIC, HYDRAULIC), KGZ (ACCESSORIES, CATHETER), FFX (SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)), FEN (Device, Cystometric, Hydraulic)

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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