Hangzhou Rollmed Co L T D

FDA Filings

This page includes the latest FDA filings for Hangzhou Rollmed 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: 3013530901
• FEI Number: 3013530901
• Name: HANGZHOU ROLLMED CO.,LTD.
• Owner & Operator: Hangzhou Rollmed Co.,Ltd.
• Contact Address: Room 913, Yuanmao Mansion No.5, Wen Er West Road, Xihu district,; Hangzhou CN-33 Zhejiang 310012 CN
• Official Correspondent:
  • Martin LAI
  • 86-571-88863507-x
• US Agent:
  • Hui Hong
  • ABMED SERVICE INC
  • 213 3753998
  • info@abmed.com.cn
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Room 913, Yuanmao Mansion No.5, Wen Er West Road, Xihu district,; Hangzhou Zhejiang, 310012 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QKO HANGZHOU ROLLMED CO.,LTD.	COVID-19(SARS-CoV-2)IgM/IgG Antibody Test Kit(Colloidal Gold)	2020-03-24
QKO HANGZHOU ROLLMED CO.,LTD.	COVID-19(SARS-CoV-2)Ig M Antibody Test Kit(Colloidal Gold)	2020-03-24
QKO HANGZHOU ROLLMED CO.,LTD.	COVID- 19(SARS-CoV-2)IgG Antibody Test Kit(Colloid al Gold)	2020-03-24
KHA HANGZHOU ROLLMED CO.,LTD.	Mask, Face Mask, Nonwoven Face Mask, Disposable Medical face Mask,Daily protective mask, N95 protective mask	2020-03-24
HOY HANGZHOU ROLLMED CO.,LTD.	Goggles	2020-03-16
PVD HANGZHOU ROLLMED CO.,LTD.	MET	2020-03-12
GQS HANGZHOU ROLLMED CO.,LTD.	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	2020-03-12
GQR HANGZHOU ROLLMED CO.,LTD.	Influenza A&B	2020-03-12
GNX HANGZHOU ROLLMED CO.,LTD.	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	2020-03-12
GNT HANGZHOU ROLLMED CO.,LTD.	Antigens, Ha (Including Ha Control), Influenza Virus A, B, C	2020-03-12
DDZ HANGZHOU ROLLMED CO.,LTD.	FIT test cassette(stool occulit blood)	2020-03-12
LXG HANGZHOU ROLLMED CO.,LTD.	Cryo tube, Cell Spreader, Loops, PCR Tube, PCR Plate	2019-07-22
FSM HANGZHOU ROLLMED CO.,LTD.	Centrifuge Tube Rack, Test Tube Rack, Staining Jar and Racks	2019-07-22
KJA HANGZHOU ROLLMED CO.,LTD.	Flask	2018-11-29
KJA HANGZHOU ROLLMED CO.,LTD.	Beaker	2018-11-29
KGB HANGZHOU ROLLMED CO.,LTD.	Nonrebreathing mask	2018-11-29
ECX HANGZHOU ROLLMED CO.,LTD.	Cylinder	2018-11-29
CAE HANGZHOU ROLLMED CO.,LTD.	Oropharyngeal Airway	2018-11-29
BYO HANGZHOU ROLLMED CO.,LTD.	Reagent Bottle	2018-11-29
BSJ HANGZHOU ROLLMED CO.,LTD.	Anaesthesia Mask	2018-11-29
HIB HANGZHOU ROLLMED CO.,LTD.	Vaginal speculum	2018-11-22
EYR HANGZHOU ROLLMED CO.,LTD.	Tourniquet	2018-11-22
FRI HANGZHOU ROLLMED CO.,LTD.	Scale	2018-11-21
LDE HANGZHOU ROLLMED CO.,LTD.	Stethoscope	2018-03-14
HGN HANGZHOU ROLLMED CO.,LTD.	stethoscope	2018-03-14
PCE HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
MGO HANGZHOU ROLLMED CO.,LTD.	Wound plaster	2017-12-06
KNO HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
KID HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
KHY HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
ITJ HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
INP HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
INE HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
INB HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
INA HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMZ HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMY HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMX HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMW HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMS HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMR HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMQ HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMP HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMO HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMN HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
IMM HANGZHOU ROLLMED CO.,LTD.	Wheelchair	2017-12-06
MHW HANGZHOU ROLLMED CO.,LTD.	bandage	2017-12-04
KGX HANGZHOU ROLLMED CO.,LTD.	MGO	2017-12-04
ITG HANGZHOU ROLLMED CO.,LTD.	bandage	2017-12-04
INF HANGZHOU ROLLMED CO.,LTD.	scale	2017-12-04
HMP HANGZHOU ROLLMED CO.,LTD.	eyp pad	2017-12-04
FRW HANGZHOU ROLLMED CO.,LTD.	Baby scale	2017-12-04
FQM HANGZHOU ROLLMED CO.,LTD.	bandage	2017-12-04
EMN HANGZHOU ROLLMED CO.,LTD.	scale	2017-12-04
DYN HANGZHOU ROLLMED CO.,LTD.	saliva ejector	2017-12-04
BZS HANGZHOU ROLLMED CO.,LTD.	stethoscope	2017-12-04
NNK HANGZHOU ROLLMED CO.,LTD.	Cardboard slides mailers/sildes mailers	2017-01-22
KYW HANGZHOU ROLLMED CO.,LTD.	Medcine cup	2017-01-22
KXG HANGZHOU ROLLMED CO.,LTD.	swab applicator	2017-01-22
KXF HANGZHOU ROLLMED CO.,LTD.	swab applicator	2017-01-22
KJG HANGZHOU ROLLMED CO.,LTD.	test tube	2017-01-22
KIZ HANGZHOU ROLLMED CO.,LTD.	petri dish	2017-01-22
KES HANGZHOU ROLLMED CO.,LTD.	Microscope slides/Microscope Cover glass	2017-01-22
KER HANGZHOU ROLLMED CO.,LTD.	urine container/stool container/Embedding cassettes	2017-01-22
JRQ HANGZHOU ROLLMED CO.,LTD.	ptfe megnetic stir bar	2017-01-22
JRC HANGZHOU ROLLMED CO.,LTD.	pipette tips	2017-01-22
JQC HANGZHOU ROLLMED CO.,LTD.	centrifuge/centrifuge tube	2017-01-22
GLE HANGZHOU ROLLMED CO.,LTD.	singel-use container for human venous blood specimen collection	2017-01-22
GJW HANGZHOU ROLLMED CO.,LTD.	pasteur pipettes	2017-01-22
GIO HANGZHOU ROLLMED CO.,LTD.	vacuum blood tube	2017-01-22
OVR HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
OEA HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
NNZ HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
NAB HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
LRW HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
KBL HANGZHOU ROLLMED CO.,LTD.	wooden tongue depressors	2016-12-21
GDY HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
FYF HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
FYE HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
FXP HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
FAQ HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
EPE HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
EFN HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21
BYG HANGZHOU ROLLMED CO.,LTD.	ROLLMED	2016-12-21

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092548740	57037 -> Long Beach, California	FACE MASK	50 PKG
2020090155458	Shanghai ,China (Mainland) -> Long Beach, California	SPECIMAN BAG	50 PKG
2020082714197	Port Bustamante,Jamaica -> San Juan, Puerto Rico	EXTRACTION GAUZE PIPETTE	450 CTN
2020070221099	Shanghai ,China (Mainland) -> Long Beach, California	FACE MASK	364 CTN
2020061752654	Shanghai ,China (Mainland) -> Long Beach, California	FACE MASK	364 CTN
2020051818113	Panama Canal - Caribbean,Panama -> San Juan, Puerto Rico	SWAB STICK	75 CTN
201812112244	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	SLIDE URINE BAG SWAB STICK ESR SET PIPETTE TOURNIQUET EXTRACTION GAUZE	455 CTN
201812043424	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	SLIDE URINE BAG SWAB STICK ESR SET PIPETTE TOURNIQUET EXTRACTION GAUZE	455 CTN