Bulb, Inflation, for Endoscope

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, concentrated in Shanghai, Guangdong and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

MDF Instruments Medifriend Inc. Shanghai
Ningbo Albert Novosino Co., Ltd. Zhejiang, contract manufacturer
Shanghai FLY Medical Devices Co., Ltd. Shanghai
Yangjiang Kaimi Import Export Co., Ltd. Guangdong

What Is This Device?

An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.

What Is FDA Product Code FCY?

Bulb, Inflation, For Endoscope is FDA product code FCY, Class 1, 21 CFR 876.1500.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Bulb, Inflation, For Endoscope

AutoSink Adapter, Fuji Duodenoscope With Ercp

Catalogue number T9-ADPT-2F, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Colorectal Air Syringe-LP

Expedite and standardize the 'bubble test' for colorectal anastomoses.

Bulb, Inflation, For Endoscope

AutoSink Adapter, Olympus Ultrasound Gastroscope, No Aux Water

Catalogue number T9-ADPT-2O, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Bulb, Inflation, for Endoscope

BELLOWS PUMP through channels

Bulb, Inflation, For Endoscope

AutoSink Adapter, Olympus Bronchoscope

Catalogue number T9-ADPT-4O, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

AutoSink Adapter, Olympus Colonoscope, Gastroscope With Aux Water Channel

2 catalogue numbers from T9-ADPT-1O, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

AutoSink With Endoscope Leak Tester

The AutoSink supplements the manual cleaning process of endoscopes with added efficiencies and automations. Additionally providing early detection of small holes in the exterior of an…

Bulb, Inflation, For Endoscope

Bulb, Inflation, for Endoscope

Catalogue number IBS001, listed by Ningbo Albert Novosino Co., Ltd., China, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Sonata® Iuus Probe Leak Tester Kit

Invasive medical device leak tester, mechanical.

Bulb, Inflation, For Endoscope

Dovideq LeakControl Device

The intended use of the LeakControl is as an early detection tool in wet leak testing to detect small holes in the exterior of an endoscope.

Bulb, Inflation, For Endoscope

EndoSound® Air Leak Tester

The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable.

Bulb, Inflation, For Endoscope

AutoSink Adapter, Olympus Broncho Scope With Ultrasound

Catalogue number T9-ADPT-6O, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

LT Connector 1o

Catalogue number T9-CON-1O, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Autosink Adapter, Fuji Colonoscope With Aux Water Channel

Catalogue number T9-ADPT-1F, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

AutoSink Adapter, Karl Storz Intubation Scope

Catalogue number T9-ADPT-1KS, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Merit Medical®

2 catalogue numbers from 00884450170076, listed by Merit Medical Systems, Inc., United States, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Fujifilm

Fujifilm’s endoscope leak tester pressurizes the inside of an endoscope so its airtightness can be checked. It is an accessory used to identify leakage in the scope before the instrument…

Bulb, Inflation, For Endoscope

Sonata® Iuus Probe Leak Tester

Invasive medical device leak tester, mechanical.

Bulb, Inflation, For Endoscope

AutoSink Adapter, Pentax Colonoscope With Aux Water Channel

Catalogue number T9-ADPT-1P, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Zutron

Zutron Auto Leak Tester Power Supply

Bulb, Inflation, For Endoscope

Colorectal Air Syringe-LP EX

Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.

Bulb, Inflation, For Endoscope

Colorectal Air Syringe-OP EX

Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.

Bulb, Inflation, For Endoscope

Bariatric Air Syringe

Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sleeve gastrectomy.

Bulb, Inflation, For Endoscope

Colorectal Air Syringe-OP

Expedite and standardize the 'bubble test' for colorectal anastomoses.

Bulb, Inflation, For Endoscope

AutoSink Universal Adapter Set

Catalogue number T9-ADPT-UNI, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Bulb, Inflation, for Endoscope

Endo Leak Kit contains Endo Leak Tester, Fujifilm Adapter, Calibration Adapter, Calibration Gauge, and power supply.

Bulb, Inflation, For Endoscope

Zutron Medical

Fujifilm Leak Tester Adapter for Endo-Leak Tester (Coiled)

Bulb, Inflation, For Endoscope

AutoSink Adapter, Olympus Duodenal Scope With Washing Ercp

Catalogue number T9-ADPT-3O, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

FLY

Catalogue number FLY-BT-102, listed by Shanghai FLY Medical Devices Co., Ltd., China, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

AutoSink Adapter, Pentax Dual Channel Colonoscope

Catalogue number T9-ADPT-2P, listed by Torvan Medical Inc., Canada, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Sterile Bulb & Bladder

Catalogue number SBB-01-5, listed by Healthmark Industries Co., Inc., United States, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Disposable Bulb & Bladder

2 catalogue numbers from D30200-210, listed by Healthmark Industries Co., Inc., United States, under Bulb, Inflation, For Endoscope. 4 manufacturers in China are registered for this product code.

Bulb, Inflation, For Endoscope

Bulb, Inflation, for Endoscope

Rubber Bulb, for Insuffl. Bulb 40924

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer