Sterilance Medical Suzhou Inc

FDA Filings

This page includes the latest FDA filings for Sterilance Medical Suzhou Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3004363181

FEI Number

3004363181

Name

Owner & Operator

Sterilance Medical (Suzhou) Inc.

Contact Address

68# LiTangHe RD XiangCheng
SUZHOU CN-32 Jiangsu 215133 CN

US Agent

KEVIN WALLS
REGULATORY INSIGHT, INC.
720 9625412
720 9625413
kevin@reginsight.com

Importing Logistics Registration

Importer	Bard Healthcare. Inc
Address	201 West Anaya Road Las Milpas, TX 78577 UNITED STATES

Importing Logistics Registration

Importer	Cancer Diagnostics, Inc
Address	Box 1205 Birmingham, MI 48012 UNITED STATES

Importing Logistics Registration

Importer	Global Healthcare Partners LP
Address	11350 Old Roswell Rd. Suite 700 Alpharetta, GA 30009 UNITED STATES

Importing Logistics Registration

Importer	Hummingbird Medical, Inc.
Address	6700 Skidaway Road Savannah, GA 31406 UNITED STATES

Importing Logistics Registration

Importer	INTERNATIONAL TECHNOLOGY INDUSTRY INC.
Address	8245 Backlick Rd Lorton, VA 22079 UNITED STATES

Importing Logistics Registration

Importer	Miami Medical Equipment & Supply Corp.
Address	2150 NW 93rd Ave Miami, FL 33172 UNITED STATES

Importing Logistics Registration

Importer	MILA International, Inc.
Address	12 Price Avenue Erlanger, KY 41018 UNITED STATES

Importing Logistics Registration

Importer	Perfect Gluco Products
Address	8927 126th Street Richmond Hill, NY 11418 UNITED STATES

Importing Logistics Registration

Importer	Precision Medical Devices
Address	2 Claire Rd E Brunswick, NJ 08816 UNITED STATES

Importing Logistics Registration

Importer	Smith Medical ASD Inc
Address	6000 Nathan Lane North Minneapolis, MN 55442 UNITED STATES

Registration Status

1

Initial Importer

N

Registration Expiration

2020-04-25

Registration Address

33 Golden Eagle Lane
Littleton, CO 80127 US

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 36945630132514 Sterilance Medical (Suzhou) Inc.	STERiLANCE Flex3 Disposable Safety Lancet	2024-10-31
GUDID 36945630132507 Sterilance Medical (Suzhou) Inc.	STERiLANCE Press2 Disposable Safety Lancet	2024-10-31
GUDID 36945630132491 Sterilance Medical (Suzhou) Inc.	STERiLANCE Press2 Disposable Safety Lancet	2024-10-31
GUDID 36945630132484 Sterilance Medical (Suzhou) Inc.	STERiLANCE Press2 Disposable Safety Lancet	2024-10-31
GUDID 36945630132477 Sterilance Medical (Suzhou) Inc.	STERiLANCE Press2 Disposable Safety Lancet	2024-10-31
GUDID 36945630132460 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-10-31
GUDID 36945630132446 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-10-31
GUDID 36945630132439 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-10-31
GUDID 26945630132531 Sterilance Medical (Suzhou) Inc.	STERiLANCE Soft Disposable Blood Lancet	2024-10-31
GUDID 26945630132524 Sterilance Medical (Suzhou) Inc.	STERiLANCE LDE4 Lancing Device	2024-10-31
GUDID 36945630132453 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-10-30
GUDID 36945630132408 Sterilance Medical (Suzhou) Inc.	STERiLANCE Press2 Disposable Safety Lancet	2024-10-25
GUDID 36945630132392 Sterilance Medical (Suzhou) Inc.	STERiLANCE Press2 Disposable Safety Lancet	2024-10-25
GUDID 36945630131081 Sterilance Medical (Suzhou) Inc.	STERiLANCE Press2 Disposable Safety Lancet	2024-09-12
GUDID 36945630129491 Sterilance Medical (Suzhou) Inc.	STERiLANCE Impress Pro Disposable Safety Lancet	2024-05-31
GUDID 06945630126994 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Pro Disposable Safety Lancet	2024-05-30
GUDID 06945630126987 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Pro Disposable Safety Lancet	2024-05-30
GUDID 06945630126970 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Pro Disposable Safety Lancet	2024-05-30
GUDID 06945630126963 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Pro Disposable Safety Lancet	2024-05-30
GUDID 06945630126956 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-05-30
GUDID 06945630126949 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-05-30
GUDID 06945630126932 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-05-30
GUDID 06945630126925 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-05-30
GUDID 06945630126918 Sterilance Medical (Suzhou) Inc.	STERiLANCE Elite Disposable Safety Lancet	2024-05-30
GUDID 26945630125779 Sterilance Medical (Suzhou) Inc.	PRESS DISPOSABLE SAFETY LANCET	2024-05-09
GUDID 36945630125752 Sterilance Medical (Suzhou) Inc.	EXALANCE LDE4 Lancing Device	2024-05-02
GUDID 06945630125522 Sterilance Medical (Suzhou) Inc.	STERiLANCE SteriHeel Plus Heel Incision Safety Lancet	2024-04-17
GUDID 26945630125120 Sterilance Medical (Suzhou) Inc.	Disposable Safety Lancet Press2	2024-04-08
GUDID 36945630124106 Sterilance Medical (Suzhou) Inc.	neoheel	2024-02-16
GUDID 36945630121815 Sterilance Medical (Suzhou) Inc.	neoheel	2024-02-16
GUDID 36945630121808 Sterilance Medical (Suzhou) Inc.	neoheel	2024-02-16
GUDID 06945630121821 Sterilance Medical (Suzhou) Inc.	neoheel	2024-02-16
GUDID 26945630122877 Sterilance Medical (Suzhou) Inc.	Soft	2024-02-08
GUDID 26945630122860 Sterilance Medical (Suzhou) Inc.	Soft	2024-02-08
GUDID 26945630122853 Sterilance Medical (Suzhou) Inc.	Soft	2024-02-08
GUDID 26945630122846 Sterilance Medical (Suzhou) Inc.	Soft	2024-02-08
GUDID 36945630123512 Sterilance Medical (Suzhou) Inc.	SteriLance Softsense Lancet 33G	2024-01-23
GUDID 36945630123505 Sterilance Medical (Suzhou) Inc.	SteriLance Softsense Lancet 30G	2024-01-23
GUDID 36945630123499 Sterilance Medical (Suzhou) Inc.	SteriLance Softsense Lancet 28G	2024-01-23
GUDID 36945630123482 Sterilance Medical (Suzhou) Inc.	SteriLance OneStep	2024-01-23
GUDID 36945630123475 Sterilance Medical (Suzhou) Inc.	SteriLance Elite Pro safety lancet 28G	2024-01-23
GUDID 36945630123468 Sterilance Medical (Suzhou) Inc.	SteriLance Elite Pro safety lancet 26G	2024-01-23
GUDID 36945630123451 Sterilance Medical (Suzhou) Inc.	SteriLance Elite Pro safety lancet 23G	2024-01-23
GUDID 36945630123444 Sterilance Medical (Suzhou) Inc.	SteriLance Elite Pro safety lancet 21G	2024-01-23
GUDID 36945630123437 Sterilance Medical (Suzhou) Inc.	SteriLance Elite safety lancet 30G 1.5mm	2024-01-23
GUDID 36945630123420 Sterilance Medical (Suzhou) Inc.	SteriLance Elite safety lancet 28G 1.8mm	2024-01-23
GUDID 36945630123413 Sterilance Medical (Suzhou) Inc.	SteriLance Elite safety lancet 26G 2.2mm	2024-01-23
GUDID 36945630123406 Sterilance Medical (Suzhou) Inc.	SteriLance Elite safety lancet 21G 1.8mm	2024-01-23
GUDID 36945630123390 Sterilance Medical (Suzhou) Inc.	SteriLance Elite safety lancet 17G 2.0mm	2024-01-23
GUDID 36945630123383 Sterilance Medical (Suzhou) Inc.	SteriLance Impress Pro safety lancet 30G 1.5mm	2024-01-23
GUDID 36945630123376 Sterilance Medical (Suzhou) Inc.	SteriLance Impress Pro safety lancet 28G 1.8mm	2024-01-23
GUDID 36945630123369 Sterilance Medical (Suzhou) Inc.	SteriLance Impress Pro safety lancet 26G 1.8mm	2024-01-23
GUDID 36945630123352 Sterilance Medical (Suzhou) Inc.	SteriLance Impress Pro safety lancet 21G 1.8mm	2024-01-23
GUDID 36945630123345 Sterilance Medical (Suzhou) Inc.	SteriLance Impress Pro safety lancet 21G 2.2mm	2024-01-23
GUDID 36945630123338 Sterilance Medical (Suzhou) Inc.	SteriLance Impress safety lancet 30G 1.5mm	2024-01-23
GUDID 36945630123321 Sterilance Medical (Suzhou) Inc.	SteriLance Impress safety lancet 28G 1.8mm	2024-01-23
GUDID 36945630123314 Sterilance Medical (Suzhou) Inc.	SteriLance Impress safety lancet 26G 1.8mm	2024-01-23
GUDID 36945630123307 Sterilance Medical (Suzhou) Inc.	SteriLance Impress safety lancet 21G 1.8mm	2024-01-23
GUDID 36945630123291 Sterilance Medical (Suzhou) Inc.	SteriLance Impress safety lancet 21G 2.2mm	2024-01-23
GUDID 36945630123178 Sterilance Medical (Suzhou) Inc.	SteriLance Lite3 Safety Lancet 30G 1.5mm	2024-01-23
GUDID 36945630123161 Sterilance Medical (Suzhou) Inc.	Sterilance Press Plus Safety Lancet 30G 1.5mm	2024-01-23
GUDID 36945630123154 Sterilance Medical (Suzhou) Inc.	Sterilance Press Plus Safety Lancet 26G 1.8mm	2024-01-23
GUDID 36945630123147 Sterilance Medical (Suzhou) Inc.	Sterilance Press Plus Safety Lancet 28G 1.8mm	2024-01-23
GUDID 36945630123130 Sterilance Medical (Suzhou) Inc.	Sterilance Press2 Safety Lancet 30G 1.5mm	2024-01-23
GUDID 36945630123123 Sterilance Medical (Suzhou) Inc.	Sterilance Press2 Safety Lancet 26G 1.8mm	2024-01-23
GUDID 36945630123116 Sterilance Medical (Suzhou) Inc.	Sterilance Press2 Safety Lancet 28G 1.8mm	2024-01-23
GUDID 36945630123109 Sterilance Medical (Suzhou) Inc.	Sterilance Press Safety Lancet 30G 1.5mm	2024-01-23
GUDID 36945630123093 Sterilance Medical (Suzhou) Inc.	Sterilance Press Safety Lancet 26G 1.8mm	2024-01-23
GUDID 36945630123086 Sterilance Medical (Suzhou) Inc.	Sterilance Press Safety Lancet 28G 1.8mm	2024-01-23
GUDID 36945630123079 Sterilance Medical (Suzhou) Inc.	Sterilance Soft Lancet 26G	2024-01-23
GUDID 36945630123062 Sterilance Medical (Suzhou) Inc.	Sterilance Soft Lancet 33G	2024-01-23
GUDID 36945630123055 Sterilance Medical (Suzhou) Inc.	Sterilance Soft Lancet 28G	2024-01-22
GUDID 36945630122478 Sterilance Medical (Suzhou) Inc.	Soft Twist Lancets 01-0132	2023-12-11
GUDID 36945630121662 Sterilance Medical (Suzhou) Inc.	VIAMED SURGICAL BLADES	2023-11-08
GUDID 06945630121463 Sterilance Medical (Suzhou) Inc.	iGlucose	2023-10-30
GUDID 06945630109836 Sterilance Medical (Suzhou) Inc.	MINICOLLECT PIXIE Heel Incision Safety Lancet	2023-10-26
GUDID 06945630109829 Sterilance Medical (Suzhou) Inc.	MINICOLLECT PIXIE Heel Incision Safety Lancet	2023-10-26
GUDID 26945630121252 Sterilance Medical (Suzhou) Inc.	Sterile Blood Lancet	2023-10-09
GUDID 36945630121013 Sterilance Medical (Suzhou) Inc.	Telli Health	2023-09-08
GUDID 36945630120429 Sterilance Medical (Suzhou) Inc.	SMARTMETER	2023-08-08
GUDID 36945630119294 Sterilance Medical (Suzhou) Inc.	STERILANCE Lite 3 30G 1.8mm	2023-06-08
GUDID 36945630113629 Sterilance Medical (Suzhou) Inc.	neoheel	2023-05-17
GUDID 36945630113612 Sterilance Medical (Suzhou) Inc.	neoheel	2023-05-17
GUDID 36945630113605 Sterilance Medical (Suzhou) Inc.	neoheel	2023-05-17
GUDID 36945630113599 Sterilance Medical (Suzhou) Inc.	neoheel	2023-05-17
GUDID 36945630117443 Sterilance Medical (Suzhou) Inc.	SURGICAL BLADE	2023-03-29
GUDID 36945630117436 Sterilance Medical (Suzhou) Inc.	SURGICAL BLADE	2023-03-29
GUDID 36945630117252 Sterilance Medical (Suzhou) Inc.	Sterilance Soft Disposable Blood Lancet	2023-03-21
GUDID 26945630117187 Sterilance Medical (Suzhou) Inc.	STERILANCE Soft Disposable Blood Lancet	2023-03-14
GUDID 36945630116514 Sterilance Medical (Suzhou) Inc.	Sterilance Press2 Pius Disposable Safety Lancet	2023-02-20
GUDID 36945630116507 Sterilance Medical (Suzhou) Inc.	Sterilance Press2 Pius Disposable Safety Lancet	2023-02-20
GUDID 36945630115081 Sterilance Medical (Suzhou) Inc.	Sterilance Press2 Disposable Safety Lancet	2022-12-08
GUDID 36945630115074 Sterilance Medical (Suzhou) Inc.	Sterilance Press2 Disposable Safety Lancet	2022-12-08
GUDID 36945630115029 Sterilance Medical (Suzhou) Inc.	Index Asurity Disposable Safety Scalpel	2022-12-08
GUDID 36945630115012 Sterilance Medical (Suzhou) Inc.	Sterilance SteriHeel Plus Heel Incision Safety Lancet	2022-12-08
GUDID 36945630115005 Sterilance Medical (Suzhou) Inc.	Sterilance SteriHeel Plus Heel Incision Safety Lancet	2022-12-08
GUDID 36945630114992 Sterilance Medical (Suzhou) Inc.	Sterilance SteriHeel Plus Heel Incision Safety Lancet	2022-12-08
GUDID 36945630114862 Sterilance Medical (Suzhou) Inc.	Sterilance Press Plus	2022-11-21
GUDID 36945630114855 Sterilance Medical (Suzhou) Inc.	Sterilance Press Plus	2022-11-21
GUDID 36945630114718 Sterilance Medical (Suzhou) Inc.	Gluco Perfect Lancets Lancetas	2022-11-08
PMN K221521 SteriLance Medical (Suzhou) Inc.	Disposable Safety Lancet	2022-10-28
PMN K221507 SteriLance Medical (Suzhou) Inc.	Disposable Blood Lancet	2022-08-31
PMN K210745 SteriLance Medical (Suzhou) Inc.	Heel Incision Safety Lancet	2021-08-26
PMN K153706 \| FMI KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Easydrip Disposable Insulin Needle	2016-08-31
PMN K153706 STERILANCE MEDICAL (SUZHOU) INC.	Insulin Pen Needle	2016-08-29
IME KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	ice bag	2016-08-12
GDZ KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Index Asurity	2014-05-12
GES KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Skin Graft Knife Blade	2013-12-30
GES KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Blades	2013-12-30
GDX KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Scalpel	2005-02-02
GDX KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Safety Protected blade System	2005-02-02
GDX KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Mini Disposable Scalpel	2005-02-02
GDX KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Index handle	2005-02-02
GDX KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Disposable Safety Scalpel	2005-02-02
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Ultra-Safe	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Twist lancets	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	SteriHeel	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	SteriHeel Plus	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Softtwins	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Softsure	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft9	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft8	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft7	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft6	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft5	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft4	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft3	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft2	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft11	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Soft10	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Press4	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Press3	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Press2	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	PA	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	NanoSense	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	NanoSense/AST	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Lite2	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	LDE	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	LDE4	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	LDE4/AST	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	LDE3	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	LDE3/AST	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	LDE2	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	LDE2/AST	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	LDE Plus	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Impress	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Imflex	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Heel	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Flex	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Flex3	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Flex2	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Elite	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Disposable steel lancet	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Disposable lancets	2003-11-26
FMK KEVIN WALLS [Sterilance Medical (Suzhou) Inc.]	Clix	2003-11-26

Related Finance Registrations

NCAGE Code	SKF76	STERILANCE MEDICAL SUZHOU INC
CAGE Code	SKF76	STERILANCE MEDICAL SUZHOU INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092921225	Shanghai ,China (Mainland) -> Los Angeles, California	STEEL SCALPEL	34 CTN
2020092323797	Shanghai ,China (Mainland) -> Los Angeles, California	STEEL SCALPEL	34 CTN
2020091940894	Shanghai ,China (Mainland) -> Long Beach, California	STEEL LANCET	3 PKG
2020091833868	Shanghai ,China (Mainland) -> Long Beach, California	STEEL LANCET	3 PKG
2020091771651	Shanghai ,China (Mainland) -> Long Beach, California	STEEL LANCET	3 PKG
2020091760096	Shanghai ,China (Mainland) -> Los Angeles, California	STEEL SCALPEL	34 CTN
2020091639019	Shanghai ,China (Mainland) -> Los Angeles, California	STEEL SCALPEL	34 CTN
2020091647599	Shanghai ,China (Mainland) -> Long Beach, California	LANCETS SOFT	500 CTN

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