Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Endoscopic video imaging system
Device Explorer · FDA GUDID · GMDN 35616

Endoscopic video imaging system

An assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with lig

US‑registered devices78in commercial distribution
Companies6labelers on GUDID
Single‑use13%of device records
Sterile13%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Smith & Nephew, Inc.5976%
Biovision Technologies, Llc1215%
Gimmi Gmbh34%
Biomet Microfixation, Inc23%
Schölly Fiberoptic Gmbh11%
Karl Storz Gmbh & Co. Kg11%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.5976%
Biovision Technologies, Llc1215%
Gimmi Gmbh34%
Biomet Microfixation, Inc23%
Schölly Fiberoptic Gmbh11%
Karl Storz Gmbh & Co. Kg11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAGimmin.a.660 HD660HD660Software LENS Tablet ApplicationLENS AntennaLENS660HD-E IMAGE MANAGEMENT SYSTEM660HD-E Image Management SystemKIT Danish 660HD-E IMSKit Portuguese 660HD-E IMSKIT, US LENS Integrated SystemN/A640 IMS

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

FDA product codes

CodeNameDevices
GCJLaparoscope, general & plastic surgery33
GCJLaparoscope, General & Plastic Surgery16
LMBDevice, digital image storage, radiological15
HRXArthroscope12
FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO10
FETEndoscopic video imaging system/component, gastroenterology-3

GMDN & GCC registration

  • GMDN code 35616 · non‑implantable
  • Single‑use 13% · sterile 13% · Rx‑only 96% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 10Length (Millimeter) · 9Angle (degree) · 9

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How many endoscopic video imaging system products are registered in the US?

78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic video imaging system", from 6 companies. The largest labeler is Smith & Nephew, Inc. with 76% of records.

Which FDA product codes apply?

GCJ (Laparoscope, general & plastic surgery), GCJ (Laparoscope, General & Plastic Surgery), LMB (Device, digital image storage, radiological), HRX (Arthroscope)

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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