Disinfector, Medical Devices

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Fujian and Jiangsu, and 1 other province: 9 hold an FDA registration. 2 are contract manufacturers.

Aopu Lighting (Jinyun) Co., Ltd. Zhejiang, contract manufacturer
Dongguan I-Believe Electronic Appliance Co., Ltd. Guangdong
Dongguan Yingfeng Metal & Plastic Products Co., Ltd. Guangdong, contract manufacturer
Guangdong Eraclean Technology Co., Ltd. Guangdong
Medease Life Co., Ltd. Jiangsu, contract manufacturer
Shenzhen Denco Medical Co., Ltd. Guangdong, contract manufacturer
Shenzhen Rogin Medical Co., Ltd. Guangdong, contract manufacturer
Xiamen Forsound Hearing Technology Co., Ltd. Fujian, contract manufacturer
Zhongshan Sunclean Co., Ltd. Guangdong

What Is FDA Product Code MEC?

Disinfector, Medical Devices is FDA product code MEC, Class 2, 21 CFR 880.6992.

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.

What Do the Recalls Say?

The FDA has recorded 31 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Device Design (6), Nonconforming Material/Component (5) and Process control (4).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Disinfector, Medical Devices

Getinge WD 14 Tablo

Getinge WD14 Tablo, Washer Disinfector

Disinfector, Medical Devices

Sterling P/M1000 Support

Support for 16 OP-shoes / 2 per rack

Disinfector, Medical Devices

Getinge WD 15 Claro

Getinge WD 15 Claro, Washer Disinfector

Disinfector, Medical Devices

Sterling P/M1000 Flexible Rack for Washing in 4 Levels

Flexible Rack for washing in 4 levels

Disinfector, Medical Devices

Roscoe

ULTRA-5 Ultraviolet Disinfector (UV-C) - Cpap, Cpap Accessories, Multipurpose Sanitizer

Disinfector, Medical Devices

Sterling P/M1000 Da Vinci Xi Stapler Holder

Da Vinci Xi Stapler holder

Disinfector, Medical Devices

Sterling P/M1000 Cover for Condenser Recycle

Cover for condenser recycle

Disinfector, Medical Devices

Sterling P/M1000 MIC Module

Sterling P/M1000 MIC module for Flexible 5 level rack

Disinfector, Medical Devices

Skytron Enzymatic Cleaner

Detergent, Enzymatic instrument, 5 gallon container with 70mm cap

Disinfector, Medical Devices

Miele

This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental…

Disinfector, Medical Devices

Flex – Standard Luer Connector Kit

Catalogue number CS-1002-000, listed by Skytron, LLC, United States, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Sterling P/M1000 Condenser Recycle Water and Heat 60 Hz, 480v

Condenser recycle water and heat 60 Hz, 480V

Disinfector, Medical Devices

Sterling P/M1000 Condenser Basic 50+60 HZ

Condenser Basic 50+60 HZ

Disinfector, Medical Devices

Flex – Da Vinci Si Tooling Connector Assembly Kit

Catalogue number CS-1001-000, listed by Skytron, LLC, United States, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Sonopro

SONOPRO is a limited pre-production run of Automated Disinfector Devices. It is classified by the FDA as a Class II medical device, product code MEC. It is intended for use in the critical…

Disinfector, Medical Devices

Skytron Sterling P1500 FLX3 Wash Rack

Flexible load carrier for processing in 3 levels w/ removable grids and spray arms

Disinfector, Medical Devices

Tonowash

Device for automatically disinfecting tonometer tips

Disinfector, Medical Devices

Sterling P/M1000 Da Vinci Rack

Da Vinci rack without holders Si, Xi

Disinfector, Medical Devices

W&H

washer disinfector

Disinfector, Medical Devices

Sterling P/M1000 Da Vinci SingleSite Holder

Da Vinci SingleSite holder

Disinfector, Medical Devices

UV Smart

2 catalogue numbers from D25V2, listed by UV Smart Technologies B.V., Netherlands, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Sterling P/M1000 Basket

Basket for 4 washing bowls / 2 per level

Disinfector, Medical Devices

Sky-Lube

Instrument Lubricant, 5 gallon container with 61mm cap

Disinfector, Medical Devices

Auto Wash

Instrument Concentrate Solution, 5 gallon container with 61mm cap

Disinfector, Medical Devices

Mocom

Tethys H10 is intended only for the washing and/or thermal disinfection of re-usable surgical instruments able to resist to a temperature of at least 80°C.

Disinfector, Medical Devices

Sterling Washer

Sterling P1500 single bay automated unloading system, for clean side

Disinfector, Medical Devices

Sterling P/M1000 Flexible Rack for Washing in 5 Levels

Flexible Rack for washing in 5 levels

Disinfector, Medical Devices

Skytron Neutral Ph Detergent Low Foam

Skytron Neutral pH Detergent Low Foam, 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

Skytron Cart Wash Detergent

Skytron Sterling Cart Wash Detergent, 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

Sterling P/M1000 Manual Loading Cart

Manual loading cart

Disinfector, Medical Devices

Sterling P/M1000 High Speed Module, 480v

High speed module, 480V

Disinfector, Medical Devices

Sterling P/M1000 Da Vinci Si Stapler Holder

Da Vinci Si Stapler holder

Disinfector, Medical Devices

Sterling P/M1000 Condenser High Speed 60 Hz, 480v

Condenser High speed 60 Hz, 480V

Disinfector, Medical Devices

Getinge 91-SERIES

WASHER DISINFECTOR 9122 AWRFS. Customized 9122-002 equipped with Automatic Water Rack Flush System (AWRFS).

Disinfector, Medical Devices

Lube-Zyme

Multi Purpose Concentrate Solution, 5 gallon container with 61mm cap

Disinfector, Medical Devices

Zoey CPAP Cleaner

CPAP Cleaning Device

Disinfector, Medical Devices

Mada Medical Products, Inc.

An electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are…

Disinfector, Medical Devices

Sterling

P/M1000 MIS Rack with accessories

Disinfector, Medical Devices

Sterling P/M1000 Conductivity Sensor

Conductivity sensor

Disinfector, Medical Devices

Sterling P/M1000 Module

Module f Ophthalmology Instruments

Disinfector, Medical Devices

Skytron Lubricant

Concentrate, lubricant, 5 gallon container with 61mm cap

Disinfector, Medical Devices

Sterling P/M1000 Rack

Rack for 96 Babybottles 125 ml

Disinfector, Medical Devices

Skytron Surg-Enz Multi-Enzymatic Cleaner

Multi-Enzymatic Cleaner, QTY 2, 2.5 gallon containers

Disinfector, Medical Devices

CPAP Cleaning

CPAP Cleaning Wipes - 64 wipes/pack

Disinfector, Medical Devices

Reliance

The Reliance 1227 Cart and Utensil Washer Disinfector is a high-capacity mechanical washer intended for use in the cleaning and low-Level disinfecting of bedpans and urinals, basins, case…

Disinfector, Medical Devices

Flex – Suction Tool Instrument Connector

Catalogue number CS-1000-000, listed by Skytron, LLC, United States, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Hydrim C61WD G4 Instrument Washer-Disinfector

Automated instrument washer-disinfector with built-in connectivity for a lumens cleaning system.

Disinfector, Medical Devices

Disinfector, Medical Devices

6 catalogue numbers from WD 290, listed by Belimed AG, Switzerland, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Sterling P/M1000 Anaesthesia Rack

Anaesthesia rack complete for IQ5

Disinfector, Medical Devices

Sterling P/M1000 MIC Rack

MIC rack complete with 40 basic nozzles for the M/P1000

Disinfector, Medical Devices

GloTran VHP Plasma Disinfector

Catalogue number GT35H, listed by You First Services, Inc., United States, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Getinge 86-SERIES

WASHER DISINFECTOR Catalog number was S-86661001. Catalog number updated to S-86662001 in November 2018.

Disinfector, Medical Devices

Stet Clean

Stet Clean: 1 catalogue number listed by Light Progress SRL, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Sterling P1000 Washer Disintector

Single, Auto Door, 208V, Electric

Disinfector, Medical Devices

Skytron Sclf Neutral Ph Detergent LF 2x Conc.

Skytron SCLF Neutral pH Detergent LF 2x Conc., 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

Germicidal Deodorizing Cleanser

Citrus II Germicidal Deodorizing Cleaner - 22oz Spray - Each

Disinfector, Medical Devices

Skytron Cart Rinse and Drying Agent

Skytron Cart Rinse and Drying Agent, 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

Verify

Verify ALL Clean Test Indicator / QTY OF 40

Disinfector, Medical Devices

Flex – Da Vinci Xi Connector Kit

Catalogue number CS-1003-000, listed by Skytron, LLC, United States, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Steelco

Washer-Disinfector

Disinfector, Medical Devices

Sterling P/M1000 Da Vinci Si Holder

Da Vinci Xi holder 8 mm + single-site instrument

Disinfector, Medical Devices

Getinge 88-SERIES

Getinge WD88 Turbo SW, Washer Disinfector

Disinfector, Medical Devices

Getinge CM320-SERIES

CM320-4 CHAMBER WUWD. Washer disinfector with four chambers; Washer chamber followed by Ultra-sonic chamber, washer chamber and dryer chamber.

Disinfector, Medical Devices

Getinge 46-SERIES

WASHER DISINFECTOR 46-5 S+W D, S+W D indicating a single door washer disinfector with dryer. This is a customized version of 46-5-402 with water inlet through the roof plate and signal…

Disinfector, Medical Devices

Flex Surgical Instrument Washer

Catalogue number CS-0040-000, listed by Skytron, LLC, United States, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Getinge 9100-SERIES

Washer Disinfector 9122EW

Disinfector, Medical Devices

Vision

The Vision Single-Chamber Washer Disinfector is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals,…

Disinfector, Medical Devices

Miele

Washer-Disinfector

Disinfector, Medical Devices

Niagara

Xi Multi Basket and tubing is used with the InnoWave Pro and PCF Pro Sonic Irrigators

Disinfector, Medical Devices

Sterling P/M1000 Flexible Rack

Flexible Rack for washing in 3 levels

Disinfector, Medical Devices

InnoWave

The InnoWave PCF Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer Disinfector for the medical market. It is intended to provide ultrasonic cleaning and low-level thermal…

Disinfector, Medical Devices

Skytron Sterling Lubricant

Skytron Sterling Lubricant, 2 x conc., low foam, 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

CleanStart

CleanStart Neutral pH Non-Enzymatic Low Foam Detergent 2.5 gal

Disinfector, Medical Devices

Reliance Vision

The Reliance Vision Single-Chamber Washer Disinfector, Electric Unit is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware,…

Disinfector, Medical Devices

Sterling M1000

M1000 S480E, Single door, Electric, 480V

Disinfector, Medical Devices

Skytron Medi-Sheen

Skytron Medi-Sheen (stain & rust remover) 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

Stet Cube

Stet Cube: 1 catalogue number listed by Light Progress SRL, under Disinfector, Medical Devices. 9 manufacturers in China are registered for this product code.

Disinfector, Medical Devices

Sterling C2000

Electric heated 480V Long Wide Version 1200 mm (47 1/4 inch) Wide x 3000mm (118 7/64 inch) Long

Disinfector, Medical Devices

Sterling P/M1000 Container Rack

Container rack 600x300x150

Disinfector, Medical Devices

Skytron Scope-Zyme Multi Enzymatic Cleaner

Skytron Scope-Zyme Multi Enzymatic Cleaner, 2 x conc., low foam, 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

Disinfector, Medical Devices

The Niagara MED1437 3-5 Level Carriers, multi-use carriers, allows the removal of shelves which turns a 5 Level carrier into a 3 Level carrier allowing for the reprocessing of instrument…

Disinfector, Medical Devices

Getinge 90-SERIES

Washer Disinfector 9027

Disinfector, Medical Devices

Skytron Moderate Alkaline Detergent

Moderate Alkaline Detergent, 2 x conc., low foam, 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

CPAP Cleaner

Sunset CPAP Mask Cleaning Wipes -Bulk- 12/case

Disinfector, Medical Devices

Skytron Sclf Multi-Enzymatic Cleaner

Skytron SCLF Multi-Enzymatic Cleaner, 2 x conc., low foam, 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

Disinfector, Medical Devices

The Multi-Function Rack for Large Items is designed to be used in the washer/disinfector for the efficient cleaning, rinsing, drying and intermediate Level disinfection of different types…

Disinfector, Medical Devices

Sterling Washers

Sterling P1500, 2-door, glass w. drying module, incl. Flow control on all dosing pumps, 3 water connections, 208V, electric heat

Disinfector, Medical Devices

Hydrim C61WD G4 Instrument Washer-Disinfector

Automated instrument washer-disinfector with built-in connectivity for a lumens cleaning system.

Disinfector, Medical Devices

I-Series Washers

I5 Washer Disinfector w/ single automated door 35.5"W x 33"D x 79"H, hot, cold and fil rinse water, 2 chemical pumps, integrated dryer, drain cool down, 4 level rack, Selectable…

Disinfector, Medical Devices

Sterling P1800

Base glassware rack for washing in 3 levels. Incl. 1 full level shelf and 2 half level shelves for P1800

Disinfector, Medical Devices

Skytron Acidic Neutralizer

Skytron Acidic Neutralizer, 2 x conc., low foam, 5 GAL JUG, 70MM CAP

Disinfector, Medical Devices

Getinge Aquadis 56

Washer disinfector

Disinfector, Medical Devices

Sterling P/M1000 Condenser High Speed 60 Hz

Condenser High speed 60 Hz, 208V

Disinfector, Medical Devices

Accessory

Accessory - Injector Cart 12 Connections

Disinfector, Medical Devices

Sterling P/M1000 High Speed Module

High speed module, 208V

Disinfector, Medical Devices

Amsco

The AMSCO 7053L Single-Chamber Washer/Disinfector meets the demands for the highest-volume sterile processing departments. It is designed for cleaning and intermediate-level disinfection of…

Disinfector, Medical Devices

Steelco

This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental…

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