Sterilant, Medical Devices

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Zhejiang. All of them are contract manufacturers, able to build to a buyer’s own specification.

Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code MED?

Sterilant, Medical Devices is FDA product code MED, Class 2, 21 CFR 880.6885.

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

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 21 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Process control (4), Device Design (4) and Nonconforming Material/Component (3).

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

Sterilant, Medical Devices

Cetylcide-G

Disinfectant-Sterilant

Sterilant, Medical Devices

Capsule Polishing Cannulae

21g x 7/8" Cap Polisher

Sterilant, Medical Devices

HLD Starter Kit

HLD Starter Kit for use wit ASTRA

Sterilant, Medical Devices

Compliance

Sterilizing and Disinfecting Solution 7.35% Hydrogen Peroxide

Sterilant, Medical Devices

MEGA3

MEGA3 3% Glutaraldehyde Gallon Bottle

Sterilant, Medical Devices

TD-12®

PAA High-Level Disinfectant

Sterilant, Medical Devices

IMCO-Micro-Scientific

Catalogue number G28-IMC, listed by Independent Medical Co-OP, Inc., under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

Silicone Tipped Polishers

27g x 7/8" Sil Tip Pol

Sterilant, Medical Devices

MetriCide OPA Plus

orthoPhthalaldehyde Solution high level disinfectant for semicritical medical devices

Sterilant, Medical Devices

System 1 Endo Liquid Chemical Sterilant Processing System

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical…

Sterilant, Medical Devices

Revital-Ox

Revital-Ox PAA HLD Solution Part B is used Revital-Ox PAA HLD Part A and the enspire 300 Series Automated Endoscope Reprocessor

Sterilant, Medical Devices

Aerozyme™ Xtra

AEROZYME™ XTRA Multi Enzymatic Detergent

Sterilant, Medical Devices

Aldahol 1.8

Catalogue number 4 x 1 gallon case, listed by Alden Medical LLC, United States, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

Maxicide

Catalogue number 1022866, listed by Henry Schein, Inc., United States, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

Scleral Markers

3.5 x 4mm Scleral Marker

Sterilant, Medical Devices

V-Cide

Formaldehyde Device Sterilant

Sterilant, Medical Devices

Acecide-C

2 catalogue numbers from Acecide-C (PLAC01), listed by Best Sanitizers, Inc., United States, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

Irrigation/Aspiration Cannulae

21g x 1 1/2" Str Cannula

Sterilant, Medical Devices

V-Cide

Chemical Sterilant, Formaldehyde

Sterilant, Medical Devices

Revital-Ox Resert

Revital-Ox Resert High Level Disinfectant is a reusable high level disinfectant for processing semi-critical medical devices for which alternative methods of terminal processing are not…

Sterilant, Medical Devices

Biotrol

Biotrol Biocide G30 Glutaraldehyde, Instrument Cleaner, 1 Gallon x 4ct

Sterilant, Medical Devices

MetriCide

Sterilizing & Disinfecting Solution 14Day Glutaraldehyde Dialdehyde Solution 2.6% Glutaraldehyde

Sterilant, Medical Devices

System 1 Endo

SYSTEM 1 endo Liquid Chemical Sterilant Processing System with Touchscreen is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive,…

Sterilant, Medical Devices

Banicide Plus Sterilizing and Disinfecting Solution

Reusable 3.4% Glutaraldehyde Sterilizing & Disinfecting Solution; 1 gallon Sterilization, high level disinfection and cleaning/decontamination solution.

Sterilant, Medical Devices

Tec-Cide Plus

Tec-Cide Plus Glutaraldehyde 3%, Gallon

Sterilant, Medical Devices

Anaesthetic Cannulae

19g x 1" Sub Tenon

Sterilant, Medical Devices

Advance Dental Products

Advance Glutaraldehyde 2.65%

Sterilant, Medical Devices

ASP Aero-OPA™

ASP AERO-OPA™ ortho-Phthalaldehyde Solution

Sterilant, Medical Devices

Maxicide Plus

2 catalogue numbers from 1025796, listed by Henry Schein, Inc., United States, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

AquaCide®

PAA Cleaner High-Level Disinfectant

Sterilant, Medical Devices

Sklar®

High Level Glutaraldehyde Disinfecting Solution

Sterilant, Medical Devices

SporGon

SporGon is a sterilant cleaning solution used in labs to clean surfaces, equipment and medical devices.

Sterilant, Medical Devices

Backflush Aspiration Handpieces

Act/Pass Backflush 23g

Sterilant, Medical Devices

UltrOx

UltrOx High Level Disinfectant

Sterilant, Medical Devices

Micro-Scientific

Micro-Cide 28 HLD - 3 % Glutaraldehyde Reusable Sterilizing and High Level Disinfecting Solution

Sterilant, Medical Devices

Rapicide High Level Disinfectant and Sterilant

Catalogue number ML02-0059, listed by Medivators Inc, United States, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

Heavy Liquid Infusion Cannulae

23g Perfluorocarbon Cann

Sterilant, Medical Devices

Aldahol 1.8

Catalogue number 4 x 1 gallon case, listed by DFB Technology, Ltd, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

MetriCide Plus 30

Sterilizing & Disinfecting Solution 28Day Glutaraldehyde Dialdehyde Solution 3.4% Glutaraldehyde

Sterilant, Medical Devices

Anterior Cannula

23g (0.64) x 30mm Spatulated Irrigation Cannula

Sterilant, Medical Devices

Nucleus Removal Cannulae

25g x 1 1/2" Vectis

Sterilant, Medical Devices

Vitreoretinal Handpieces

Backflush/25g Soft Tip

Sterilant, Medical Devices

Peracidin RO Disinfectant

Peracidin® RO Disinfectant is intended for the disinfection of water purification systems for hemodialysis.

Sterilant, Medical Devices

A.C. Maintainers

23g ACM Lewicky

Sterilant, Medical Devices

Prevention

A reusable high level disinfectant solution designed to be used with heat sensitive medical devices and instruments, for which heat sterilization is not suitable.

Sterilant, Medical Devices

Patterson®

Sterilant, Medical Devices

Sterilant, Medical Devices

Intradermal Cannulae

Intradermal Cannulae SILKANN CANNULA 18gx70mm

Sterilant, Medical Devices

Cortex Removal Cannulae

23g x 7/8" Cortex Ext

Sterilant, Medical Devices

Handpieces and Cannulae

Charles Flute Hnd/Cannula

Sterilant, Medical Devices

Rapicide OPA/28 High-Level Disinfectant

Catalogue number ML02-0127, listed by Medivators Inc, United States, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

Wash out Cannulae

16g x 1" Washout Cannula

Sterilant, Medical Devices

Biocide G30

Glutaraldehyde cold sterilant

Sterilant, Medical Devices

Endothelial Polishing Cannula

27g x 7/8" Sil Tip Pol

Sterilant, Medical Devices

Sterilant, Medical Devices

Adapter FOR 70K With FWJ

Sterilant, Medical Devices

Maxicide 28 Day

2 catalogue numbers from 1026003, listed by Henry Schein, Inc., United States, under Sterilant, Medical Devices. 1 manufacturer in China is registered for this product code.

Sterilant, Medical Devices

Cannulae Olive Tipped Cannulae

23g x 1" Olive Tipped Pol

Sterilant, Medical Devices

System 1e Liquid Chemical Sterilant Processing System – Reworked Placement Progr

The SYSTEM 1E Liquid Chemical Sterilant Processing System is for safe and effective reprocessing of heat-sensitive critical and semi-critical medical devices. This unit is distributed…

Sterilant, Medical Devices

Darby Dental Supply, LLC

Glutaraldehyde 3.4% Gallon

Sterilant, Medical Devices

Z3

Benco Z3 2.5% 28 DAY GLUT

Sterilant, Medical Devices

Wavicide-01

Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.

Sterilant, Medical Devices

Intradermal Needles

30g TW x 12.7mm Long Hypo

Sterilant, Medical Devices

ProCide-D Plus

Sterilizing & Disinfecting Solution 28Day Glutaraldehyde Dialdehyde Solution 3.4% Glutaraldehyde

Sterilant, Medical Devices

Nexadental

bottle

Sterilant, Medical Devices

Coecide™ XL

COECIDE™ XL Plus 1 gallon liquid with 158g activator

Sterilant, Medical Devices

Henry Schein

Maxicide Activated

Sterilant, Medical Devices

Serim® Disintek™ GTA 1.5% Test Strips

Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Minimum Effective Concentration (MEC) of 1.5% for CIDEX® or…

Sterilant, Medical Devices

Cidex™

CIDEX™ Instrument tray System 381 mm x 594 mm x 141 mm

Sterilant, Medical Devices

Exactech

EXACTECH® CoCr FEM HEAD, 22mm O.D., +10, 12/14

Sterilant, Medical Devices

MetriCide28

Sterilizing & Disinfecting Solution 28Day Glutaraldehyde Dialdehyde Solution 2.5% Glutaraldehyde

Sterilant, Medical Devices

Pro Advantage

Pro Advantage Glutaraldehyde 14 Gallon

Sterilant, Medical Devices

Enspire

The enspire 300 Series Automated Endoscope Reprocessor, 208V, Non-vented, Wall Drain is designed to effectively test, clean, high level disinfect, rinse and air purge up to two…

Sterilant, Medical Devices

Refractive Cannulae

25g x 1 1/8" Buratto Lasi

Sterilant, Medical Devices

McKesson

Solution, Glut+ 3.4% 28DAY QT

Sterilant, Medical Devices

Sporox ® II

Sporox® II Sterilizing & Disinfecting Solution, 8 oz bottles, 6 pack

Sterilant, Medical Devices

Bimanual I/A Systems

21g TW x 16mm Bimanual

Sterilant, Medical Devices

Viscoelastic Cannulae

27g x 7/8" Viscoelastic

Sterilant, Medical Devices

Crosstex International

SaniGlut Glutaraldehyde

Sterilant, Medical Devices

Coaxial Cannulae and Hand Pieces

16/21g I/A Handpiece 45Â°

Sterilant, Medical Devices

Formed Capsularhexis Cystotomes

25g x 5/8" Cyst Short Cvd

Sterilant, Medical Devices

Quick Connect

The Quick Connect for Pentax Ultrasound Videoscopes is used with the C3000XL Ultrasound Processing Tray in the SYSTEM 1E and, or SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.

Sterilant, Medical Devices

ProCide-D

Sterilizing & Disinfecting Solution 28Day Glutaraldehyde Dialdehyde Solution 2.5% Glutaraldehyde

Sterilant, Medical Devices

S40

The S40 Sterilant Concentrate is a single use peracetic acid-based chemistry used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.

Sterilant, Medical Devices

Lachrymal Cannulae

26g x 1 1/4" Lachrymal

Sterilant, Medical Devices

Micro-X

Micro-X Dialyzer Reprocessing Concentrate

Sterilant, Medical Devices

Bimanual Cannulae and Hand Pieces

21g x 5/8" Bimanual Irr

Sterilant, Medical Devices

Sterilant, Medical Devices

The Quick Connects for Pentax X/00/01/P Series Gastroscopes without Water Jets are and VSB-2900 used with C1160E Universal Flexible Processing Trays in the System 1E Liquid Chemical…

Sterilant, Medical Devices

Intradermal Cannulae and Needles

Silkann(FT) Cann 25gx40mm

Sterilant, Medical Devices

Vitreoretinal Cannulae

23g x 1 1/4" Asp Cann

Sterilant, Medical Devices

Medline

OPA Disinfectant, 28 DAY, 4 X 1 Gall

Sterilant, Medical Devices

Anterior Chamber Maintenance Cannulae

Anterior Chamber Maintenance Cannulae 27g x 7/8" Ant Chamber

Sterilant, Medical Devices

Anaesthetic Needles

27g x 1 1/4" (0.4 x 32mm) Peribulbar Needle

Sterilant, Medical Devices

Peracidin®

Dialyzer Reprocessing Concentrate and RO Disinfectant

Sterilant, Medical Devices

Peracidin

Peracidin - Dialyzer reprocessing concentrate and RO Disinfectant, Peracetic acid. 55 gal drum

Sterilant, Medical Devices

Cerec® Essentials Featuring Preventive Solutions

CEREC® Omnicam High Level Disinfection Preventative Care Kit

Sterilant, Medical Devices

Sterilant, Medical Devices

The Quick Connect for Intuitive Surgical Ion Fully Articulating Catheter and Peripheral Vision Probe used with the C1220E Directed Flow Processing Container and Tray when used in the SYSTEM…

Sterilant, Medical Devices

Formed Irrigating Cystotomes

25g x 5/8" Cyst Short Cvd

Sterilant, Medical Devices

Hydrodissection Cannulae

27 g x 7/8" (0,4 x 22 mm) Hydrodisektor Helsinki

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