This page includes the latest FDA filings for Universal Electronics Whitewater. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3002736372 |
| FEI Number | 3004631140 |
| Name | UNIVERSAL ELECTRONICS, INC. |
| Owner & Operator | UNIVERSAL ELECTRONICS - Whitewater |
| Contact Address | 640 N. PROSPECT DR. -- Whitewater WI 53190 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 640 N. PROSPECT DR. WHITEWATER, WI 53190 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM - System, Test, Blood Glucose, Over The Counter | 2017-12-06 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM - System, Test, Blood Glucose, Over The Counter | 2017-12-06 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM - System, Test, Blood Glucose, Over The Counter | 2017-12-06 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM - System, Test, Blood Glucose, Over The Counter | 2017-12-06 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | APNEA RISK EVALUATION SYSTEM (ARES) MODEL 620 | 2017-12-06 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | BIOSCANNER PLUS Glucose Oxidase, Glucose System, Test, Blood Glucose, Over The Counter | 2017-12-06 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | BIOSCANNER PLUS Glucose Oxidase, Glucose System, Test, Blood Glucose, Over The Counter | 2017-12-06 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | BIOSCANNER PLUS Glucose Oxidase, Glucose System, Test, Blood Glucose, Over The Counter | 2017-12-06 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | Propeller Sensor Model 2015-E | 2016-11-29 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | Propeller Sensor Model 2014-D | 2016-11-29 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | Propeller Sensor Model 2014-R | 2016-11-29 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | Propeller Sensor Model 2014-D | 2015-11-17 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | Propeller Sensor Model II Propeller Health Sensor Model II | 2015-11-17 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | GENESIS OTC MONITOR | 2013-09-04 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | CardioChek Plus Analyzer | 2013-09-04 |
UNIVERSAL ELECTRONICS, INC. [UNIVERSAL ELECTRONICS - Whitewater] | CardioChek Plus Analyzer | 2013-09-04 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020083154073 | Hong Kong,Hong Kong -> Long Beach, California | STRAP FOR HOME SLEEP TESTING DEVISE ++ EX WORK ++ PLACE OF RECEIPT:SHENZHEN,CHINA SCAC#:TECB HBL#:HKSE20070206 THIS SHIPMENT CONTAINS NO WOOD PACKING MATERIALS | 73 CTN |
| 2020083154138 | Hong Kong,Hong Kong -> Long Beach, California | PART #1014504,40500-BAT REV 2, VQ BATTERY,212030S PART #1014504,40500-BAT REV 2, VQ BATTERY,212030S ++ EX WORK ++ PLACE OF RECEIPT:SHENZHEN,CHINA SCAC#:TECB | 22 CTN |
| 2020083154192 | Hong Kong,Hong Kong -> Long Beach, California | PLEASTIC PARTS TWO PLASTIC TRAY ++ EX WORK ++ PLACE OF RECEIPT:SHENZHEN,CHINA SCAC#:GOAG HBL#HKSE20070210 THIS SHIPMENT CONTAINS NO WOOD | 2 CTN |
| 2020042337049 | Hong Kong,Hong Kong -> Long Beach, California | STRAP FOR HOME SLEEP TESTING DEVICE, PLASTIC SENSOR PADS FOR HOME SLEEP TESTING DEVICE | 30 CTN |