Safecare Biotech Hangzhou Co L T D

FDA Filings

This page includes the latest FDA filings for Safecare Biotech Hangzhou 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

3013077867

FEI Number

3013077867

Name

Owner & Operator

Safecare Biotech(Hangzhou)Co.,Ltd

Contact Address

2628 Yuhangtang Rd Cangqian Sub-district,Yuhang District
Hangzhou CN-33 Zhejiang 311121 CN

Official Correspondent

Alex Qiu
86-571-89712897-x

US Agent

Jesse Xia
301 2500831
jxia@lsi-consulting.org

Importing Logistics Registration

Importer	Best Value Medical
Address	1358 Watergap Rd Endicott, KY 41653 UNITED STATES
Phone	1 606 8743864

Importing Logistics Registration

Importer	BioTech Screening, LLC
Address	116 Haywood Court Roseville, CA 95747 UNITED STATES
Phone	1 925 2898113

Importing Logistics Registration

Importer	EqualTox Labs
Address	1562 Parway loop, ste B Tustin, CA 92780 UNITED STATES
Phone	1 714 7604804

Importing Logistics Registration

Importer	IMEX Medical
Address	22490 Cypress Wood Lane Boca Raton, FL 33428 UNITED STATES

Importing Logistics Registration

Importer	Labtech diagnostics llc
Address	1502 east Greenville st Anderson, SC 29621 UNITED STATES

Importing Logistics Registration

Importer	Med-Tech Resources, LLC
Address	12087 Sheraton Ln. Cincinnati, OH 45246 UNITED STATES

Importing Logistics Registration

Importer	Nobel Suppliers Group LLC
Address	266 47 Street Brooklyn, NY 11219 UNITED STATES
Phone	1 347 2464759

Importing Logistics Registration

Importer	Norton Health Care
Address	85 East Main Street Norton, MA 02766 UNITED STATES

Importing Logistics Registration

Importer	POC Distributors, LLC
Address	1101 Spy Glass Way Knoxville, TN 37922 UNITED STATES
Phone	1 401 6462877

Importing Logistics Registration

Importer	Terek & Co
Address	1570 Plunketts Rd. Buford, GA 30519 UNITED STATES
Phone	1 404 7047254

Registration Status

1

Initial Importer

N

Registration Expiration

2020-04-25

Registration Address

12828 Doe Ln
Darnestown, MD 20878 US

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06974246461762 Safecare Biotech (Hangzhou) Co., Ltd.	Welcheck Marijuana(THC) Urine Test Dipcard THC-1014	2024-12-06
GUDID 06974246461755 Safecare Biotech (Hangzhou) Co., Ltd.	Welcheck Marijuana(THC) Urine Test Dipcard THC-1014	2024-12-06
GUDID 06974246461670 Safecare Biotech (Hangzhou) Co., Ltd.	Welcheck URINARY TRACT INFECTION TEST UTI-1021	2024-10-24
GUDID 06974246461663 Safecare Biotech (Hangzhou) Co., Ltd.	Welcheck URINARY TRACT INFECTION TEST UTI-1021	2024-10-24
GUDID 06974246461656 Safecare Biotech (Hangzhou) Co., Ltd.	Welcheck Vaginal PH Rapid Test Cassette PH-6012	2024-10-24
GUDID 06974246461649 Safecare Biotech (Hangzhou) Co., Ltd.	Welcheck Vaginal PH Rapid Test Cassette PH-6012	2024-10-24
GUDID 06974246461632 Safecare Biotech (Hangzhou) Co., Ltd.	Welcheck Vaginal PH Rapid Test Cassette PH-6012	2024-10-24
GUDID 06974246461618 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Multi-Drug Urine Test Dip Card MDP-1064	2024-09-23
GUDID 06974246461601 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Multi-Drug Urine Test Dip Card MDP-1064	2024-09-23
GUDID 06974246461595 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Multi-Drug Urine Test Dip Card MDP-1124	2024-09-23
GUDID 06974246461588 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Multi-Drug Urine Test Dip Card MDP-1124	2024-09-23
GUDID 06974246461496 Safecare Biotech (Hangzhou) Co., Ltd.	FIRSTVIEW Fentanyl Urine Test Cassette FYL-1012	2024-07-08
GUDID 06974246461489 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Cotinine(COT) Urine Test Dipcard COT-1014	2024-07-05
GUDID 06974246461472 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Cotinine(COT) Urine Test Dipcard COT-1014	2024-07-05
GUDID 06974246461465 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Cotinine(COT) Urine Test Dipcard COT-1014	2024-07-05
GUDID 06974246461458 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Marijuana(THC) Urine Test Dipcard THC-1014	2024-07-05
GUDID 06974246461441 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Marijuana(THC) Urine Test Dipcard THC-1014	2024-07-05
GUDID 06974246461434 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Marijuana(THC) Urine Test Dipcard THC-1014	2024-07-05
GUDID 06974246461373 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Vaginal PH Rapid Test Cassette PH-6012	2024-06-07
GUDID 06974246461366 Safecare Biotech (Hangzhou) Co., Ltd.	T Testahead Vaginal PH Rapid Test Cassette PH-6012	2024-06-07
GUDID 06974246461359 Safecare Biotech (Hangzhou) Co., Ltd.	URINARY TRACT INFECTION TEST UTI-1021	2024-05-20
GUDID 06974246461342 Safecare Biotech (Hangzhou) Co., Ltd.	Vaginal PH Rapid Test Cassette PH-6012	2024-05-20
GUDID 06974246461335 Safecare Biotech (Hangzhou) Co., Ltd.	Vaginal PH Rapid Test Cassette PH-6012	2024-05-20
GUDID 06974246461328 Safecare Biotech (Hangzhou) Co., Ltd.	Vaginal PH Rapid Test Cassette PH-6012	2024-05-20
GUDID 06974246461304 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive THC Test THC-1011	2024-04-19
GUDID 06974246461298 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro 7-Panel Urine Drug Test MDP-1074	2024-04-02
GUDID 06974246461281 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro 7-Panel Urine Drug Test MDP-1074	2024-04-02
GUDID 06974246461274 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro 7-Panel Urine Drug Test MDP-1074	2024-04-02
GUDID 06974246461267 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro 7-Panel Urine Drug Test MDP-1074	2024-04-02
GUDID 06974246461250 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro 7-Panel Urine Drug Test MDP-1074	2024-04-02
GUDID 06974246461243 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro Highly Sensitive 5-Panel Urine Drug Test MDP-1054	2024-04-01
GUDID 06974246461236 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro Highly Sensitive 5-Panel Urine Drug Test MDP-1054	2024-04-01
GUDID 06974246461229 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro Highly Sensitive 5-Panel Urine Drug Test MDP-1054	2024-04-01
GUDID 06974246461212 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro Highly Sensitive 5-Panel Urine Drug Test MDP-1054	2024-04-01
GUDID 06974246461205 Safecare Biotech (Hangzhou) Co., Ltd.	Exploro Highly Sensitive 5-Panel Urine Drug Test MDP-1054	2024-04-01
GUDID 06974246460857 Safecare Biotech (Hangzhou) Co., Ltd.	FIRSTVIEW Cocaine(COC) Urine Test Dipcard COC-1014	2024-01-03
GUDID 06974246461014 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive NICOTINE URINE TEST COT200NGML	2023-12-11
GUDID 06974246461007 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive NICOTINE URINE TEST COT200NGML	2023-12-11
GUDID 06974246460994 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive NICOTINE URINE TEST COT200NGML	2023-12-11
GUDID 06974246460987 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive NICOTINE URINE TEST COT200NGML	2023-12-11
GUDID 06974246460970 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive THC Test THC50NGML	2023-12-11
GUDID 06974246460963 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive THC Test THC50NGML	2023-12-11
GUDID 06974246460956 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive THC Test THC50NGML	2023-12-11
GUDID 06974246460949 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive THC Test THC50NGML	2023-12-08
GUDID 06974246460932 Safecare Biotech (Hangzhou) Co., Ltd.	Testahead Vaginal PH Rapid Test Cassette PH-6012	2023-09-13
GUDID 06974246460871 Safecare Biotech (Hangzhou) Co., Ltd.	FIRSTVIEW Luteinizing Hormone Rapid Test Strip LH-1011	2023-09-13
GUDID 06974246460864 Safecare Biotech (Hangzhou) Co., Ltd.	FIRSTVIEW Luteinizing Hormone Rapid Test Strip LH-1011	2023-09-13
GUDID 06974246460840 Safecare Biotech (Hangzhou) Co., Ltd.	FIRSTVIEW COT Urine Dip card Test COT-1014	2023-09-13
GUDID 06974246460833 Safecare Biotech (Hangzhou) Co., Ltd.	FIRSTVIEW hCG Urine Test Strip HCG-1011	2023-09-13
GUDID 06974246460802 Safecare Biotech (Hangzhou) Co., Ltd.	FIRSTVIEW Urine Test Marijuana DipCard THC-1014	2023-09-13
GUDID 06974246460772 Safecare Biotech (Hangzhou) Co., Ltd.	EXPLORO Highly Sensitive THC Test THC-1011	2023-02-24
GUDID 06974246460765 Safecare Biotech (Hangzhou) Co., Ltd.	Luteinizing Hormone Rapid Test Strip LH-1011	2023-02-24
GUDID 06974246460727 Safecare Biotech (Hangzhou) Co., Ltd.	Highly Sensitive Nicotine Urine Test COT-1011	2023-02-24
GUDID 06974246460703 Safecare Biotech (Hangzhou) Co., Ltd.	7-Panel Urine Drug Test MDP-1074	2023-02-24
GUDID 06974246460680 Safecare Biotech (Hangzhou) Co., Ltd.	THC Urine Strip Test THC-1011	2023-02-24
GUDID 06974246460567 Safecare Biotech (Hangzhou) Co., Ltd.	THC Urine Strip Test THC-1011	2023-02-24
PMN K202453 Safecare Biotech(Hangzhou)Co.,Ltd.	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card	2021-03-24
PMN K200133 Safecare Biotech (Hangzhou) Co., Ltd.	HCG Urine Test Strip, HCG Urine Test Cassette, HCG Urine Test Midstream	2020-08-13
PMN K201120 Safecare Biotech(Hangzhou)Co.,Ltd.	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card	2020-05-27
QKO Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE 2019-nCoV IgG/IgM Rapid Test	2020-03-27
PMN K191924 \| NFW Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE? THC Urine Strip Test	2019-09-21
NGE Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Luteinizing Hormone Rapid Test Strip	2019-09-21
NGE Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Luteinizing Hormone Rapid Test Midstream	2019-09-21
NGE Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Luteinizing Hormone Rapid Test Device	2019-09-21
PMN K191924 Safecare Biotech (Hangzhou) Co., Ltd.	SAFECARE® THC Urine Strip Test	2019-08-16
PMN K182654 \| QBF Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| QBF Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| QAW Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| QAW Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| PTH Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| PTH Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| PTG Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| PTG Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| NGM Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| NGM Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| NGL Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| NGL Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| NGI Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| NGI Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| NGG Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| NGG Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| NFY Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| NFY Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| NFW Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| NFW Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| NFV Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| NFV Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 \| NFT Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test DipCard	2018-11-28
PMN K182654 \| NFT Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Multi-Drug Urine Test Cup	2018-11-28
PMN K182654 Safecare Biotech (Hangzhou) Co., Ltd.	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card	2018-11-19
PMN K181968 \| PTH Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Dip Card	2018-09-19
PMN K181968 \| PTH Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Cup	2018-09-19
PMN K181968 \| PTG Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Dip Card	2018-09-19
PMN K181968 \| PTG Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Cup	2018-09-19
PMN K181968 \| NGL Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Dip Card	2018-09-19
PMN K181968 \| NGL Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Cup	2018-09-19
PMN K181968 \| NGG Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Dip Card	2018-09-19
PMN K181968 \| NGG Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Cup	2018-09-19
PMN K181968 \| NFY Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Dip Card	2018-09-19
PMN K181968 \| NFY Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Cup	2018-09-19
PMN K181968 \| NFW Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Dip Card	2018-09-19
PMN K181968 \| NFW Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Cup	2018-09-19
PMN K181968 \| NFV Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Dip Card	2018-09-19
PMN K181968 \| NFV Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Cup	2018-09-19
PMN K181968 \| NFT Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Dip Card	2018-09-19
PMN K181968 \| NFT Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	Safecare Multi-Drug Urine Test Cup	2018-09-19
PMN K181968 Safecare Biotech(Hangzhou)Co.,Ltd.	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card	2018-08-20
PMN K153646 \| LDJ Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Marijuana	2016-06-14
PMN K153646 \| LDJ Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Cocaine	2016-06-14
PMN K153646 \| LDJ Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Amphetamine	2016-06-14
PMN K153646 \| DKZ Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Marijuana	2016-06-14
PMN K153646 \| DKZ Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Cocaine	2016-06-14
PMN K153646 \| DKZ Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Amphetamine	2016-06-14
PMN K153646 \| DIO Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Marijuana	2016-06-14
PMN K153646 \| DIO Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Cocaine	2016-06-14
PMN K153646 \| DIO Jesse Xia [Safecare Biotech(Hangzhou)Co.,Ltd]	SAFECARE Urine Test Amphetamine	2016-06-14
PMN K153646 SAFECARE BIOTECH (HANGZHOU)CO.,LTD.	SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana	2016-03-18

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020050928772	Shanghai ,China (Mainland) -> Long Beach, California	MULTI DRUGS TEST CUP	200 CTN
202002294984	Ningpo ,China (Mainland) -> Miami, Florida	RAPID TEST KIT	81 CTN
202002216544	Ningpo ,China (Mainland) -> Savannah, Georgia	RAPID TEST KIT	887 CTN
2020021411828	Ningpo ,China (Mainland) -> Savannah, Georgia	RAPID TEST KIT	887 CTN
2020011820995	57037 -> New York/Newark Area, Newark, New Jersey	URINE TEST CUP	200 CTN
2019113028389	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	RAPID TEST KIT	206 CTN
2019070618272	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	RAPID TEST KIT	100 CAR
201907015759	Shanghai ,China (Mainland) -> Miami, Florida	DIAGNOSTIC KIT	100 CTN

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