Amsino Medical Kunshan Co L T D

FDA Filings

This page includes the latest FDA filings for Amsino Medical Kunshan Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005669815
• FEI Number: 3005669815
• Name: Richard Lee
• Owner & Operator: AMSINO MEDICAL (KUNSHAN) CO., LTD.
• Contact Address: 582 LIDU ROAD, QIANDENG TOWN --; KUNSHAN CITY, JIANGSU PROVINCE CN-NOTA 215343 CN
• Official Correspondent:
  • Holiven - Ji
  • 86-512-57400615-x
• US Agent:
  • Richard Lee
  • AMSINO INTERNATIONAL, INC.
  • 909 6065888
  • 909 6263888
  • holiven_ji@amsino.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 708 Corporate Center Dr. ; Pomona, CA 91768 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K183473 | NGT Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSafe? Pre-Filled Normal Saline Flush Syringe	2019-12-20
PMN K181423 | FRO Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure? Sterile Water, and Sterile Normal Saline for Wound Flush	2018-10-15
PMN K173665 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSafe?Sure-LokTMNeedle-Free Connector	2018-10-15
BSY Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Amsino Suction Catheter kit	2016-09-27
BYX Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Aerosol Tubing	2014-03-19
PMN K070873 | LJH Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Cystoscopy & TUR Irrigation Sets	2014-03-12
KGB Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Non-rebreather Oxygen Mask	2012-08-03
GCD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	SIMS Connector	2012-08-03
GCD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	5 in 1 connector	2012-08-03
FOD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Amsino Umbilical Cord Clamp	2012-08-03
BYG Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Oxygen Mask	2012-08-03
BYG Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Aerosol Mask	2012-08-03
EZS Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Ostomy Arch	2012-03-22
FFG Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Urinemeter	2012-02-20
PMN K992719 | KNT Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Enteral Feeding Set	2012-02-10
PMN K992719 | KNT Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Enteral Delivery Gravity Set	2012-02-10
PMN K992719 | KNT Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE	2012-02-10
PMN K101958 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	IV Extension Set	2012-02-10
PMN K101958 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	IV Administration Set	2012-02-10
PMN K101958 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSafe-3 IV Set	2012-02-10
PMN K091306 | EZD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure PVC Intermittent Catheter	2012-02-10
PMN K091306 | EZD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure PVC Catheter	2012-02-10
PMN K030664 | FCM Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Foley Insertion Tray	2012-02-10
PMN K030664 | FCM Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Catheterization Tray	2012-02-10
PMN K030293 | EYB Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Red Rubber Catheter	2012-02-10
KTC Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Sitz Bath Bag	2012-02-10
KNX Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Calculi Strainer	2012-02-10
FCE Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Enema bucket set	2012-02-10
FCE Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Enema bag set	2012-02-10
FAQ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Leg Bag	2012-02-10
FAQ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Extension Tube	2012-02-10
PMN K093773 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Amsino IV Administration Set	2011-11-04
PMN K093773 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Amsafe IV Administration Set	2011-11-04
PMN K093773 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure IV Extension Set	2011-11-04
PMN K093773 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure IV Administration Set	2011-11-04
PMN K093773 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSafe IV Extension Set	2011-11-04
PMN K093773 | FPA Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSINO IV Extension Set	2011-11-04
BYY Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Amsino Suction Connecting Tube	2011-08-18
BYY Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Suction Connecting Tube	2011-08-18
PMN K050654 | LRS Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Amisno I.V. Start Kit	2010-06-15
PMN K050654 | LRS Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure I.V. Start Kit	2010-06-15
NNI Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Specimen Container	2008-09-08
PMN K050656 | MCZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Suture Removal Tray	2008-01-08
PMN K050656 | MCZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Suture Removal Kit	2008-01-08
JOL Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Suction Catheter	2007-07-17
JOL Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Suction Catheter Kit	2007-07-17
JOL Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Coiled Suction Catheter	2007-07-17
PMN K023276 | LRO Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure TRACHEOSTOMY CARE TRAY	2006-11-08
PMN K023276 | LRO Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSINO TRACHEOSTOMY CARE TRAY	2006-11-08
PMN K023276 | KDD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure TRACHEOSTOMY CARE TRAY	2006-11-08
PMN K023276 | KDD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSINO TRACHEOSTOMY CARE TRAY	2006-11-08
PMN K951528 | HIB Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Vaginal Speculum	2006-05-16
PMN K951528 | HIB Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSINO Vaginal Speculum	2006-05-16
PMN K030712 | FCM Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Urethral Catheterization Tray	2006-05-16
LRP Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Amsino Surgical Tray	2006-05-16
KDD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Shave Prep Kit	2006-05-16
KDD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Convenience Kit	2006-05-16
HTD Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Amsino Forceps	2006-05-16
BYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Mucus Trap	2006-05-16
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Irrigation Tray	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Irrigation Syringe	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Irrigation Kit	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Enteral Irrigation Kit	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Enteral Feeding Syringe	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Ear/Ulcer Syringe	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	Bulb Irrigation Syringe	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Pole Syringe	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Piston Irrigation Tray	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Irrigation Tray	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Irrigation Syringe	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Irrigation Kit	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Enteral Irrigation Kit	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Enteral Feeding Syringe	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Ear/Ulcer Syringe	2006-05-01
KYZ Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Bulb Irrigation Syringe	2006-05-01
FMH Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Urine Specimen Container	2006-05-01
FMH Richard Lee [AMSINO MEDICAL (KUNSHAN) CO., LTD.]	AMSure Specimen Container	2006-05-01

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092973941	Shanghai ,China (Mainland) -> Long Beach, California	ENTERAL FEEDING PUMP SET URETHRAL CATHETER TR AY	2406 CTN
2020092540362	Shanghai ,China (Mainland) -> Los Angeles, California	INSTR APPL F MEDICAL SURGICAL DENTAL VET N LEG BAG 9018.90.80 SHAVE PREP TRAY 8212.10.00 CLAMP	2397 CTN
2020092540363	Shanghai ,China (Mainland) -> Los Angeles, California	INSTR APPL F MEDICAL SURGICAL DENTAL VET N DIGNISHIELD BAG AMSINO I.V. SET URETHRAL CATHETER TRAY SUCTION CATHETER KIT SPECIMEN CONTAINER	2157 CTN
2020092512525	Shanghai ,China (Mainland) -> Baltimore, Maryland	TRUCATH CLOSED SYSTEM KIT CLOSED SYSTEM CATHE .	1200 CTN
2020092528853	Shanghai ,China (Mainland) -> Long Beach, California	PRE-FILLED NORMAL SALINE PRE-FILLED NORMAL SALINE FLUSH SYRINGE 10 ML FILL . 0.9% SODIUM CHLORIDE INJECTION @FAX 909-626-3888 @@TEL 714-690-3700	1680 CTN
2020092540360	Shanghai ,China (Mainland) -> Los Angeles, California	INSTR APPL F MEDICAL SURGICAL DENTAL VET N ENTERAL FEEDING PUMP SET FAX 909-626-388 8 FAX 714-690-37 01	2480 CTN
2020092540361	Shanghai ,China (Mainland) -> Los Angeles, California	INSTR APPL F MEDICAL SURGICAL DENTAL VET N URETHRAL CATHETERIZATION TRAY PVC CATHETER FAX 909-626-388 8	2030 CTN
2020092416186	Shanghai ,China (Mainland) -> Baltimore, Maryland	TRUCATH CLOSED SYSTEM KIT CLOSED SYSTEM CATHE .	1200 CTN