Universal Meditech Inc

FDA Filings

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

Universal Meditech Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Vivian Li

FDA Registration(s)

• Registration Number: 3011908678
• FEI Number: 3011908678
• Name: UNIVERSAL MEDITECH INC.
• Owner & Operator: Universal Meditech Inc.
• Contact Address: 1320 E Fortune Ave Suite 102; Fresno CA 93725 US
• Official Correspondent:
  • Yan Wang
  • 1-559-6562386-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1320 E Fortune Ave Suite 102; Fresno, CA 93725 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID B512210011 UNIVERSAL MEDITECH INC.	One Step Menopausal Test 210-01	2021-10-25
GUDID B512200011 UNIVERSAL MEDITECH INC.	One Step Ovulation Test 200-01	2021-10-25
GUDID B512100011 UNIVERSAL MEDITECH INC.	One Step Pregnancy Test 100-01	2021-10-25
PMN K020474 | MSH UNIVERSAL MEDITECH INC.	N95 Respirator	2020-04-07
GUDID 00860002273006 UNIVERSAL MEDITECH INC.	DoublecheQ Pregnancy Test 100-13	2019-08-09
GUDID 00680243766491 UNIVERSAL MEDITECH INC.	DoublecheQ Pregnancy Test 100-13	2019-06-28
PVG UNIVERSAL MEDITECH INC.	One Step Drugs of Abuse Test - MOP	2019-05-30
PVD UNIVERSAL MEDITECH INC.	One Step Drugs of Abuse Test - MET	2019-05-30
PVA UNIVERSAL MEDITECH INC.	One Step Drugs of Abuse Test - COC	2019-05-30
PUX UNIVERSAL MEDITECH INC.	One Step Drugs of Abuse Test - AMP	2019-05-30
GTY UNIVERSAL MEDITECH INC.	diagnosUS Strep A Test	2018-06-08
NGE UNIVERSAL MEDITECH INC.	Nahdi? LH Ovulation Test (Self Test - Midstream)	2017-12-26
PVH UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2017-12-15
PVK UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2017-12-08
PVJ UNIVERSAL MEDITECH INC.	One Step Drugs of Abuse Test - THC	2017-12-08
PVE UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2017-12-08
PUZ UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2017-12-08
PUY UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2017-12-08
PMN K993850 | LJX UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | LJX UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JRE UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JRE UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JMZ UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JMZ UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JMT UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JMT UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JMA UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JMA UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JJB UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JJB UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JIR UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JIR UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JIO UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JIO UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JIN UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JIN UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | JIL UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | JIL UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | CIN UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | CIN UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | CEN UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | CEN UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K993850 | CDM UNIVERSAL MEDITECH INC.	Urinalysis Test Strip (10 Parameter)	2016-03-29
PMN K993850 | CDM UNIVERSAL MEDITECH INC.	HealthyWiser pH Test Strips	2016-03-29
PMN K974060 | JHI UNIVERSAL MEDITECH INC.	One Step hCG Pregnancy Urine/Serum Combo Test Ministrip	2016-03-29
PMN K974059 | LCX UNIVERSAL MEDITECH INC.	Nahdi? Pregnancy Test (Self Test - Midstream)	2016-03-29
PMN K974059 | LCX UNIVERSAL MEDITECH INC.	DiagnosUS? Pregnancy Test - Midstream	2016-03-29
PMN K974009 | JHI UNIVERSAL MEDITECH INC.	DiagnosUS? hCG Serum/Urine Test- Cassette	2016-03-29
PMN K970176 | JJX UNIVERSAL MEDITECH INC.	hCG Control Reference Standard	2016-03-29
PMN K963133 | JHI UNIVERSAL MEDITECH INC.	One Step hCG Pregnancy Urine/Serum Combo Test Cassette	2016-03-29
PMN K963132 | JHI UNIVERSAL MEDITECH INC.	One Step hCG Pregnancy Urine/Serum Combo Test	2016-03-29
PMN K951705 | JHI UNIVERSAL MEDITECH INC.	One Step hCG Pregnancy Test Ministrip	2016-03-29
PMN K121231 | NGT UNIVERSAL MEDITECH INC.	One Step Drug of Abuse Test	2016-03-29
PMN K121231 | NGI UNIVERSAL MEDITECH INC.	One Step Drug of Abuse Test	2016-03-29
PMN K121231 | NGG UNIVERSAL MEDITECH INC.	One Step Drug of Abuse Test	2016-03-29
PMN K121231 | NFY UNIVERSAL MEDITECH INC.	One Step Drug of Abuse Test	2016-03-29
PMN K121231 | NFW UNIVERSAL MEDITECH INC.	One Step Drug of Abuse Test	2016-03-29
PMN K113506 | KHE UNIVERSAL MEDITECH INC.	DiagnosUS? Fecal Occult Blood Test	2016-03-29
PMN K110889 | LCX UNIVERSAL MEDITECH INC.	For Women's Health	2016-03-29
PMN K110889 | LCX UNIVERSAL MEDITECH INC.	DiagnosUS? hCG Urine Test - Strip	2016-03-29
PMN K103037 | NGJ UNIVERSAL MEDITECH INC.	Urinary Tract Infection Test	2016-03-29
PMN K103037 | LJX UNIVERSAL MEDITECH INC.	Urinary Tract Infection Test	2016-03-29
PMN K100031 | KHE UNIVERSAL MEDITECH INC.	One Step FOB Test	2016-03-29
PMN K063390 | LJX UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | KQO UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | JRE UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | JMT UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | JJB UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | JIR UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | JIO UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | JIN UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | JIL UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | CEN UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K063390 | CDM UNIVERSAL MEDITECH INC.	UR-50 Urine Analyzer	2016-03-29
PMN K060810 | LDJ UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2016-03-29
PMN K060810 | LAF UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2016-03-29
PMN K060810 | DKZ UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2016-03-29
PMN K060810 | DJG UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2016-03-29
PMN K060810 | DIO UNIVERSAL MEDITECH INC.	DiagnosUS? One Step Drugs of Abuse Test	2016-03-29
PMN K052694 | JHI UNIVERSAL MEDITECH INC.	One Step hCG Pregnancy Test - 2000mIU/mL	2016-03-29
PMN K052662 | CGJ UNIVERSAL MEDITECH INC.	One Step FSH Menopausal Test	2016-03-29
PMN K050741 | JHI UNIVERSAL MEDITECH INC.	DiagnosUS? hCG Urine Test - Cassette	2016-03-29
PMN K023638 | LCX UNIVERSAL MEDITECH INC.	Nahdi? Pregnancy Test (Self Test - Cassette)	2016-03-29
CEP UNIVERSAL MEDITECH INC.	One Step LH Ovulation Test	2016-03-29
CEP UNIVERSAL MEDITECH INC.	For Women's Health	2016-03-29
CEP UNIVERSAL MEDITECH INC.	DoublecheQ Ovulation Test	2016-03-29
CEP UNIVERSAL MEDITECH INC.	DiagnosUs? Ovulation Test (Strip Format)	2016-03-29

Related Finance Registrations

NCAGE Code	7TYT5	UNIVERSAL MEDITECH INC.
CAGE Code	7TYT5	UNIVERSAL MEDITECH INC.
DUNS	080243910	Universal Meditech Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090943734	Tsingtao,China (Mainland) -> Los Angeles, California	PAPER BOX PLASTIC BOTTLE PLASTIC BOARD RUBBER .	43 PKG
2020072742189	Tsingtao,China (Mainland) -> Los Angeles, California	ALUMINUM FOIL BAG PLASTIC BOTTLE PLASTIC SHEL .	149 CTN
2020060216692	Tsingtao,China (Mainland) -> Los Angeles, California	PLASTIC SHELLS DOUBLE FACED ADHESIVE TAPE EXH .	51 CTN
2020022524143	Tsingtao,China (Mainland) -> Los Angeles, California	CLEANING AGENT	107 PKG
2020022524143	Tsingtao,China (Mainland) -> Los Angeles, California	BOTTLE PLASTIC LABEL	107 PKG
2020022524143	Tsingtao,China (Mainland) -> Los Angeles, California	PLASTIC SHELL	107 PKG
2020022524143	Tsingtao,China (Mainland) -> Los Angeles, California	COLOR PAPER BOX	107 PKG
2020022524143	Tsingtao,China (Mainland) -> Los Angeles, California	PACKER	107 PKG
2020022524143	Tsingtao,China (Mainland) -> Los Angeles, California	NON-WOVEN FABRICS	107 PKG
201906086446	Tsingtao,China (Mainland) -> New York/Newark Area, Newark, New Jersey	HCG PREGNANCY TEST (COLLOIDAL GOLD)(CASSETTE) LH OVULATION TEST (COLLOIDAL GOLD)(CASSETTE) CY-DOOR FREIGHT PREPAID 880 APOLLO STREET,SUITE 175 EL	1776 PCS
2018062815486	Tsingtao,China (Mainland) -> Oakland, California	PLASTIC SHELL PRESSURE MACHINE URINALYSIS REAGENT TEST STRIP FREIGHT PREPAID CY/DOOR FAX:310-322-4801	214 PCS