Universal Electronics Inc

FDA Filings

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

FDA Registration(s)
Registration Number3002736372
FEI Number3004631140
NameUNIVERSAL ELECTRONICS, INC.
Owner & OperatorUNIVERSAL ELECTRONICS - Whitewater
Contact Address640 N. PROSPECT DR. --
Whitewater WI 53190 US
Official Correspondent
  • Walter - Holle
  • x-262-4581000-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address640 N. PROSPECT DR.
WHITEWATER, WI 53190 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM - System, Test, Blood Glucose, Over The Counter2017-12-06
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM - System, Test, Blood Glucose, Over The Counter2017-12-06
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM - System, Test, Blood Glucose, Over The Counter2017-12-06
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM - System, Test, Blood Glucose, Over The Counter2017-12-06
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
APNEA RISK EVALUATION SYSTEM (ARES) MODEL 6202017-12-06
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
BIOSCANNER PLUS Glucose Oxidase, Glucose System, Test, Blood Glucose, Over The Counter2017-12-06
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
BIOSCANNER PLUS Glucose Oxidase, Glucose System, Test, Blood Glucose, Over The Counter2017-12-06
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
BIOSCANNER PLUS Glucose Oxidase, Glucose System, Test, Blood Glucose, Over The Counter2017-12-06
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
Propeller Sensor Model 2015-E2016-11-29
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
Propeller Sensor Model 2014-D2016-11-29
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
Propeller Sensor Model 2014-R2016-11-29
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
Propeller Sensor Model 2014-D2015-11-17
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
Propeller Sensor Model II Propeller Health Sensor Model II2015-11-17
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
GENESIS OTC MONITOR2013-09-04
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
CardioChek Plus Analyzer2013-09-04
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater]
CardioChek Plus Analyzer2013-09-04

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092842351Hong Kong,Hong Kong -> Long Beach, CaliforniaANTENNA250 CTN
2020092658036Taipei,China (Taiwan) -> Los Angeles, CaliforniaAMPL HDTV ANT WHITE FABRICS SLI MIT HS CODE:852910 PO# 310/1253667 CTN
2020092418027Yantian,China (Mainland) -> Houston, TexasSMALL SPEAKER802 CTN
2020092425622Yantian,China (Mainland) -> Houston, TexasSPEAKER AND MONITOR899 CTN
2020092425622Yantian,China (Mainland) -> Houston, TexasSPEAKER AND MONITOR899 CTN
2020092247604Taipei,China (Taiwan) -> Los Angeles, CaliforniaACTIVE FLAT ANTENNA BLACK 5G MIT PO# 310/1238 ACTIVE FILM ANTENNA MIDDLE ROUND 5G MIT ACTIVE FLAT ANTENNA BLACK AGC-SLI 5G MIT PO# 310/12473168 CTN
202009192958Shanghai ,China (Mainland) -> Long Beach, CaliforniaREMOTE CONTROLLER1000 CTN
202009192941Shanghai ,China (Mainland) -> Long Beach, CaliforniaSENSOR252 CTN
2020091940547Shanghai ,China (Mainland) -> Los Angeles, CaliforniaREMOTE CONTROLLER2000 CTN

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