Runbio Biotech Co L T D

FDA Filings

This page includes the latest FDA filings for Runbio Biotech 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: 3005216656
• FEI Number: 3005216656
• Name: RUNBIO BIOTECH CO., LTD.
• Owner & Operator: RUNBIO BIOTECH CO., LTD.
• Contact Address: RONGSHONG TECHNOLOGICAL ZONE UNIVERSITY ROAD, SHANTOU; GUANGDONG CN-NOTA 515063 CN
• US Agent:
  • Kyou Hee Lee
  • 608 7705379
  • runhe0754@126.com
• Importing Logistics Registration:
  • Importer: Greenway International Corp
  • Address: #14 Guayama st. San Juan PR 00919 ; San Juan, PR 00919 UNITED STATES
  • Importer Type: AGENT
• Importing Logistics Registration:
  • Importer: Home Health Check Inc
  • Address: 105 West Areba Ave. Hershey PA ; Bachmanville, PA 17033 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: Home Health Check Inc.
  • Address: 105 West Areba Ave. Hershey PA ; Bachmanville, PA 17033 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: TestAgents LLC
  • Address: 12918 Mukilteo SPDWY C23 STE 288 ; Mukilteo, WA 98275 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: RONGSHONG TECHNOLOGICAL ZONE UNIVERSITY ROAD, SHANTOU; GUANGDONG Guangdong, 515063 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06938444982641 Runbio Biotech Co., Ltd.	DAVID	2022-07-25
GUDID 06938444982610 Runbio Biotech Co., Ltd.	DAVID	2022-07-11
GUDID 06938444982603 Runbio Biotech Co., Ltd.	DAVID	2022-07-11
GUDID 00850014758431 Runbio Biotech Co., Ltd.	NATALIST PREGNANCY TEST STRIP 15 COUNT RH-HCG-S	2022-02-04
GUDID 06938444982498 Runbio Biotech Co., Ltd.	OT80-Beurer Ovulation Predictor and Fertility Tracking Kit	2021-07-08
GUDID 06938444982481 Runbio Biotech Co., Ltd.	DAVID Ovulation Test Strip RH-LH25-S	2021-06-09
GUDID 06938444982412 Runbio Biotech Co., Ltd.	DAVID	2021-05-04
GUDID 00850014758257 Runbio Biotech Co., Ltd.	NATALIST PREGNANCY TEST MIDSTREAM 2 COUNT	2021-01-11
GUDID 00850014758240 Runbio Biotech Co., Ltd.	NATALIST OVULATION TEST STRIP 30 COUNT RH-LH-S	2021-01-11
GUDID 00850014758042 Runbio Biotech Co., Ltd.	NATALIST OVULATION TEST MIDSTREAM 10 COUNT RH-LH-B	2021-01-11
GUDID 06938444982405 Runbio Biotech Co., Ltd.	DAVID Ovulation Test RH-LH25-B	2020-12-10
GUDID 06938444982399 Runbio Biotech Co., Ltd.	DAVID Ovulation Test RH-LH25-S	2020-12-10
GUDID 06938444982382 Runbio Biotech Co., Ltd.	DAVID Pregnancy Test RH-HCG10-B	2020-12-10
GUDID 06938444982375 Runbio Biotech Co., Ltd.	DAVID Pregnancy Test	2020-12-10
GUDID 06938444982368 Runbio Biotech Co., Ltd.	DAVID Pregnancy Test	2020-12-10
GUDID 06938444982245 Runbio Biotech Co., Ltd.	SUUCARE	2020-10-19
GUDID 06938444982283 Runbio Biotech Co., Ltd.	DAVID	2020-08-12
GUDID 06938444982276 Runbio Biotech Co., Ltd.	DAVID	2020-08-12
GUDID 06938444982269 Runbio Biotech Co., Ltd.	DAVID	2020-08-12
GUDID 06938444985017 Runbio Biotech Co., Ltd.	LotFancy RH-HCG-B	2020-04-14
GUDID 06938444985000 Runbio Biotech Co., Ltd.	LotFancy	2020-04-14
GUDID 00860001730210 Runbio Biotech Co., Ltd.	Natalist Ovulation Test RH-LH-B	2020-03-27
GUDID 06938444982252 Runbio Biotech Co., Ltd.	PREGABLE Ovulation Test Kit	2020-01-17
GUDID 00850014758363 Runbio Biotech Co., Ltd.	NATALIST RH-HCG-B	2020-01-02
PMN K172627 | LCX RUNBIO BIOTECH CO., LTD.	David Professional Pregnancy Test Cassette	2019-08-15
PMN K172627 | LCX RUNBIO BIOTECH CO., LTD.	David Home Pregnancy Test Cassette	2019-08-15
PMN K172627 | JHI RUNBIO BIOTECH CO., LTD.	David Professional Pregnancy Test Cassette	2019-08-15
PMN K172627 | JHI RUNBIO BIOTECH CO., LTD.	David Home Pregnancy Test Cassette	2019-08-15
GUDID 00860001730203 Runbio Biotech Co., Ltd.	Natalist Pregnancy Test	2019-07-22
GUDID 06938444982207 Runbio Biotech Co., Ltd.	6 days Ahead Pregnancy Test (3 HCG Midstreams)	2019-07-08
GUDID 06938444982191 Runbio Biotech Co., Ltd.	Early Blush Pregnancy Test (3 HCG Midstreams)	2019-07-08
GUDID 06938444982184 Runbio Biotech Co., Ltd.	Early Blush Pregnancy Test (30 HCG Strips)	2019-07-08
GUDID 06938444982177 Runbio Biotech Co., Ltd.	Early Blush Ovulation Test Kit	2019-07-08
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	Smilereader Pregnancy Test	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	PREGABLE Pregnancy Test	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	Natalist Pregnancy Test	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	Early Blush Pregnancy Test	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	DAVID One Step Prescription Pregnancy Test Strip	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	DAVID One Step Prescription Pregnancy Test Midstream	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	DAVID One Step Prescription Pregnancy Test Cassette	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	DAVID One Step Home Use Pregnancy Test Strip	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	DAVID One Step Home Use Pregnancy Test Midstream	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	DAVID One Step Home Use Pregnancy Test Cassette	2019-04-23
PMN K181551 | LCX RUNBIO BIOTECH CO., LTD.	6 Days Ahead Pregnancy Test	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	Smilereader Pregnancy Test	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	PREGABLE Pregnancy Test	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	Natalist Pregnancy Test	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	Early Blush Pregnancy Test	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	DAVID One Step Prescription Pregnancy Test Strip	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	DAVID One Step Prescription Pregnancy Test Midstream	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	DAVID One Step Prescription Pregnancy Test Cassette	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	DAVID One Step Home Use Pregnancy Test Strip	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	DAVID One Step Home Use Pregnancy Test Midstream	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	DAVID One Step Home Use Pregnancy Test Cassette	2019-04-23
PMN K181551 | JHI RUNBIO BIOTECH CO., LTD.	6 Days Ahead Pregnancy Test	2019-04-23
GUDID 06938444981309 Runbio Biotech Co., Ltd.	DrKea+	2019-04-08
PMN K181551 Runbio BioTech Co.,Ltd	DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette	2019-02-22
GUDID 06938444981026 Runbio Biotech Co., Ltd.	Smilereader Ovulation test kit(30LH+10HCG)	2019-02-21
GUDID 06938444981019 Runbio Biotech Co., Ltd.	Smilereader ovulation test kit	2019-02-21
GUDID 06938444981002 Runbio Biotech Co., Ltd.	Smilereader ovulation test kit	2019-02-21
GUDID 06938444980173 Runbio Biotech Co., Ltd.	Emay 1	2019-02-21
GUDID 06938444980128 Runbio Biotech Co., Ltd.	DAVID OVULATION TEST KIT	2019-02-21
GUDID 06938444980036 Runbio Biotech Co., Ltd.	DAVID RH-LH-B	2019-02-21
GUDID 06938444980012 Runbio Biotech Co., Ltd.	DAVID PREGNANCY TEST MIDSTREAM RH-HCG-B	2018-07-06
GUDID 06938444980074 Runbio Biotech Co., Ltd.	DAVID Ovulation Test Midstream RH-LH-B	2018-03-29
GUDID 06938444980043 Runbio Biotech Co., Ltd.	DAVID Ovulation Test (Urine) RH-LH-S01	2018-03-29
PMN K172627 Runbio BioTech Co.,Ltd	David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette	2018-03-28
DFQ RUNBIO BIOTECH CO., LTD.	Home Sperm Marker Protein SP10 Test for Male Fertility	2018-01-19
NGA RUNBIO BIOTECH CO., LTD.	One Step FSH Urine Test	2018-01-18
OIE RUNBIO BIOTECH CO., LTD.	DAVID OVULATION TEST KIT	2016-08-12
NGE RUNBIO BIOTECH CO., LTD.	Smilereader Ovulation Test	2016-04-21
NGE RUNBIO BIOTECH CO., LTD.	PREGABLE Ovulation Test	2016-04-21
NGE RUNBIO BIOTECH CO., LTD.	Natalist Ovulation Test	2016-04-21
NGE RUNBIO BIOTECH CO., LTD.	Early Blush Ovulation Test	2016-04-21
NGE RUNBIO BIOTECH CO., LTD.	DAVID One Step Semi-quantitative Ovulation Test	2016-04-21
NGE RUNBIO BIOTECH CO., LTD.	DAVID ONE STEP OVULATION TEST STRIP	2016-04-21
NGE RUNBIO BIOTECH CO., LTD.	DAVID ONE STEP OVULATION TEST MIDSTREAM	2016-04-21
NGE RUNBIO BIOTECH CO., LTD.	DAVID ONE STEP OVULATION TEST CASSETTE	2016-04-21
PMN K053236 | LCX RUNBIO BIOTECH CO., LTD.	Smilereader pregnancy test	2006-09-25
PMN K053236 | LCX RUNBIO BIOTECH CO., LTD.	One Step Pregnancy Test	2006-09-25
PMN K053236 RUNBIO BIOTECH CO., LTD.	DAVID PREGNANCY TEST (MIDSTREAM)	2006-07-18
PMN K991067 | JHI RUNBIO BIOTECH CO., LTD.	DAVIDSTRIP HCG	2005-06-17

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082559789	Yantian,China (Mainland) -> Los Angeles, California	OVULATION TEST	40 CTN
2020070834569	Yantian,China (Mainland) -> Los Angeles, California	PREGNANCY TEST STRIPS STICKS,OVULATION TEST S TRIPS STICKS	67 CTN
2020070426928	Yantian,China (Mainland) -> Los Angeles, California	PREGNANCY TEST STRIPS STICKS,OVULATION TEST S TRIPS STICKS	67 CTN
2020021819033	Hong Kong,Hong Kong -> Los Angeles, California	PREGNANCY TEST HS CODE 3822001000	168 CTN
2019092315951	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PREGNANCY TEST HS CODE 300215 OVULATION TEST HS CODE 382200	58 CTN
2018060750656	Hong Kong,Hong Kong -> Long Beach, California	SMILEREADER OVULATION TEST KIT, 5 OVULATION TEST STRIP AND 1 PREGNANCY TEST STRIP INSIDE 1 BOX WITH MAMUAL SMILEREADER OVULATION TEST KIT, 15 OVULATION TEST STRIP AND 5 PREGNANCY TEST STRIP INSIDE 1	61 CTN