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Data / Medical devices / System, Test, Blood Glucose, Over The Counter

System, Test, Blood Glucose, Over The Counter (NBW): 107 FDA-registered makers in 16 countries

107 establishments in 16 countries are registered with the FDA to make System, Test, Blood Glucose, Over The Counter (product code NBW, Class 2, 21 CFR 862.1345). 68 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 513 510(k) clearances under this code, the latest on October 23, 2026, and lists 75 recall events (6 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
NBW
Device class
2
Regulation
862.1345
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States42
China18
Taiwan14
South Korea8
Japan4
Poland3
United Kingdom3
Mexico3
Switzerland2
Ireland2
Germany2
Vietnam2
Philippines1
Malaysia1
Indonesia1
India1

Makers of System, Test, Blood Glucose, Over The Counter

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Taidoc Technology CorporationNew Taipei City, TaiwanContract manufacturer, Manufacturer32June 16, 2022000api.fda.gov
Ascensia Diabetes Care Holdings AGBasel Basel-Stadt, SwitzerlandSpecification developer16August 27, 2026000api.fda.gov
Ascensia Diabetes Care Poland Sp. z o.o.Warszawa Mazowieckie, PolandSpecification developer16August 27, 2026000api.fda.gov
Ascensia Diabetes Care US Inc.Parsippany, NJ, United StatesSpecification developer16August 27, 2026000api.fda.gov
Ascensia Diabetes Care US Inc.Valhalla, NY, United StatesComplaint file establishment, Specification developer16August 27, 2026010api.fda.gov
Ok Biotech Co., Ltd.HSINCHU CITY Hsinchu(County), TaiwanContract manufacturer, Manufacturer15September 15, 2017000api.fda.gov
I-Sens, Inc.Seoul, South KoreaSpecification developer14August 10, 2023000api.fda.gov
i-SENS Wonju FactoryWonju-si Gangwon, South KoreaContract manufacturer, Manufacturer14August 10, 2023000api.fda.gov
I-SENS Songdo Factory 2lncheon Incheon, South KoreaManufacturer13August 10, 2023000api.fda.gov
Abbott Diabetes Care Inc.Alameda, CA, United StatesComplaint file establishment, Manufacturer, Specification developer11September 27, 20170133api.fda.gov
Bionime CorporationTaichung City, TaiwanExporter to the US, Manufacturer10November 4, 2024000api.fda.gov
i-SENS Songdo FactoryIncheon, South KoreaContract manufacturer, Manufacturer10August 10, 2023000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer, Specification developer9October 10, 2025000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer, Manufacturer8September 24, 2014000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer, Repackager or relabeler8September 27, 2017000api.fda.gov
Trividia Health, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer8July 23, 2026061api.fda.gov
Abbott Diabetes Care LimitedWITNEY OXON Oxfordshire, United KingdomManufacturer7September 27, 2017000api.fda.gov
Roche Diabetes Care, Inc.Indianapolis, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer7May 6, 2022050api.fda.gov
Apex Biotechnology Corp.HSINCHU Hsinchu(County), TaiwanContract manufacturer, Exporter to the US, Manufacturer, Specification developer6November 4, 2022000api.fda.gov
HMD Biomedical, Inc.Hsinchu County Hsinchu(County), TaiwanContract manufacturer, Exporter to the US, Manufacturer6August 29, 2022000api.fda.gov
Nova Biomedical Corporation Diabetes ProductsBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export6June 23, 2016000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer6June 23, 2016000api.fda.gov
Polymer Technology SystemsWhitestown, IN, United StatesManufacturer6February 26, 2022050api.fda.gov
AgamatrixDerry, NH, United StatesComplaint file establishment, Manufacturer, Specification developer5June 6, 2024000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Specification developer5June 23, 2016011api.fda.gov
OSANG Healthcare CO., LTD.ANYANG Gyeonggi, South KoreaContract manufacturer, Manufacturer5July 13, 2021000api.fda.gov
RR Donnelley GTS Poland Sp. z o.o.Lodz Lodzkie, PolandContract manufacturer, Exporter to the US, Manufacturer5June 28, 2012000api.fda.gov
Tyson Bioresearch, Inc.Zhunan Township Miaoli, TaiwanExporter to the US, Manufacturer5November 30, 2018000api.fda.gov
Eps Bio Technology Corp.Hsinchu Hsinchu(County), TaiwanManufacturer4February 27, 2014000api.fda.gov
Lifescan Europe GMBHCH Zug, SwitzerlandSpecification developer4February 14, 2020000api.fda.gov
Metene LimitedCity of Industry, CA, United StatesSpecification developer4May 8, 2019000api.fda.gov
Tianjin Empecs Medical Device Co., Ltd.Tianjin, ChinaManufacturer4June 7, 2017000api.fda.gov
Abbott Ireland Diabetes CareDonegal Town, IrelandManufacturer3June 5, 2015000api.fda.gov
Dongguan Honfield Precision Parts Co., LtdZhangmutou, Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Repackager or relabeler3March 23, 2018000api.fda.gov
Guangdong Transtek Medical Electronics Co.,ltdZhongshan Guangdong, ChinaExporter to the US, Manufacturer3January 30, 2025000api.fda.gov
LifeScan U.S. LLCMalvern, PA, United StatesSpecification developer3October 5, 2007000api.fda.gov
Osang LLCS Pasadena, CA, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer3October 16, 2020000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer, Repackager or relabeler3April 21, 2017000api.fda.gov
Visgeneer, Inc.HSINCHU CITY Hsinchu(City), TaiwanManufacturer3August 15, 2013000api.fda.gov
Vivachek Biotech (hangzhou) Co., LtdHangzhou, Zhuji Zhejiang, ChinaContract manufacturer, Manufacturer3August 16, 2024000api.fda.gov
Andon Health Co., LtdTianjin, ChinaExporter to the US, Manufacturer, Specification developer2February 1, 2019000api.fda.gov
All Medicus Co., Ltd.Anyang-si Gyeonggi, South KoreaManufacturer2October 13, 2017000api.fda.gov
Bioland Technology Ltd.SHENZHEN Guangdong, ChinaManufacturer2August 12, 2022000api.fda.gov
Cambridge Sensors LimitedHUNTINGDON, Cambridgeshire, United KingdomManufacturer2November 19, 2009010api.fda.gov
Changsha Sinocare Inc.Changsha Hunan, ChinaManufacturer2December 1, 2023000api.fda.gov
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer2March 20, 2020000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Remanufacturer, Repackager or relabeler2June 21, 2013000api.fda.gov
Golden Smart Home Technology Corp.Hsinchu City Hsinchu(City), TaiwanManufacturer2September 15, 2017000api.fda.gov
IMPILO, Inc.Philadelphia, PA, United StatesContract manufacturer, Repackager or relabeler2March 20, 2020000api.fda.gov
Optum Distribution Center, LLCMarietta, GA, United StatesManufacturer2December 23, 2021000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler2March 15, 2013000api.fda.gov
SD Biosensor, Inc.Suwon-si Gyeonggi, South KoreaSpecification developer2October 17, 2017000api.fda.gov
SD Biosensor, Inc.Cheongju-si Chungbuk, South KoreaManufacturer2October 17, 2017000api.fda.gov
Alliance International Medical Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer1April 20, 2015000api.fda.gov
AnriwellRiverside, CA, United StatesRepackager or relabeler, Specification developer1March 20, 2020000api.fda.gov
Bioptik Technology, Inc.Jhunan Township Miaoli, TaiwanManufacturer1March 1, 2006000api.fda.gov
Care Living Diagnostics IncSouth Setauket, NY, United StatesSpecification developer1December 9, 2005000api.fda.gov
Global Instrumentation Corp.New Taipei, TaiwanContract manufacturer, Exporter to the US1October 17, 2013000api.fda.gov
Ixensor Co LtdTaipei, TaiwanManufacturer1November 2, 2017000api.fda.gov
Mediusa Inc.Los Angeles, CA, United StatesRemanufacturer, Repackager or relabeler1November 10, 2016000api.fda.gov
Microtech Medical (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Manufacturer1September 11, 2020000api.fda.gov
Mio Labs Inc.Franklin D Roosevelt, NY, United StatesManufacturer1June 28, 2023000api.fda.gov
Rasimo Systems LLCRaleigh, NC, United StatesSpecification developer1November 10, 2016000api.fda.gov
Rosie Connectivity Solutions, Inc.Savannah, GA, United StatesRemanufacturer, Repackager or relabeler, Specification developer1June 28, 2010000api.fda.gov
Sejoy Biomedical Co., Ltd.Hangzhou City Zhejiang, ChinaManufacturer1October 8, 2024000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer1November 10, 2016000api.fda.gov
Teladoc Health, Inc. - LewisvilleLewisville, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1January 30, 2025000api.fda.gov
Telcare, LLCLinwood, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1July 28, 2011010api.fda.gov
Acon Biotech (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
ALOM Technologies CorporationIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
ARKRAY Factory, Inc.Koka-shi Shiga, JapanManufacturer0000api.fda.gov
ARKRAY Industry West Inc.Rosario Cavite, PhilippinesContract manufacturer, Manufacturer0000api.fda.gov
Arkray, Inc.Kamigyo-ku Kyoto, JapanSpecification developer0000api.fda.gov
Abbott Ireland, ADC KilkennyKilkenny, IrelandManufacturer0000api.fda.gov
Altek Medical (kunshan) limitedKunshan Free Trade Zone Jiangsu, ChinaContract manufacturer0000api.fda.gov
Altek Medical Sdn. Bhd.Iskandar Puteri Johor, MalaysiaContract manufacturer0000api.fda.gov
Andon Medical co., LTDTianjin, ChinaContract manufacturer0000api.fda.gov
BOI(VIETNAM) Company LtdNenh Ward Bac Ninh, VietnamContract manufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesManufacturer0000api.fda.gov
Conductive Technologies, Inc.York, PA, United StatesContract manufacturer0000api.fda.gov
Clinico Medical Sp. z o.o.Blonie/Miekinia Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
Dongguan Kaifa Technology Co.,ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Flextronics America, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
Flextronics Industrial (Shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Flextronics International USABuffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Flextronics Manufacturing Aguascalientes, S.A de C.VAguascalientes, MexicoContract manufacturer0000api.fda.gov
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
GL Diabetes CorporationSan Diego, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
IMPILO - PHL KubachPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov
Impilo PhoenixPhoenix, AZ, United StatesContract manufacturer0000api.fda.gov
Insulet CorporationActon, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Lifescan Scotland LtdINVERNESS Highland, United KingdomContract manufacturer0000api.fda.gov
Lre Medical GMBHNOERDLINGEN Bavaria, GermanyContract manufacturer0000api.fda.gov
Maq-Ops, S. De R.L.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
PHC CorporationTOON Ehime, JapanContract manufacturer0000api.fda.gov
PHC CorporationMIMA Tokushima, JapanContract manufacturer0000api.fda.gov
PT PHC IndonesiaCikarang Barat Bekasi Jawa Barat, IndonesiaContract manufacturer0000api.fda.gov
Partron VINA DONG SOC BRANCHVinh Tuong Commune Phu Tho, VietnamContract manufacturer0000api.fda.gov
RR Donnelley Global Turnkey SolutionsJuarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shenzhen Creative Industry Co., LtdSHENZHEN Guangdong, ChinaManufacturer0000api.fda.gov
SanminaKunshan Jiangsu, ChinaContract manufacturer0000api.fda.gov
Sanmina-SCI India Pvt LtdOragadam Tamil Nadu, IndiaContract manufacturer0000api.fda.gov
Trividia Health Taiwan, INC.HSINCHU CITY Hsinchu(City), TaiwanContract manufacturer0000api.fda.gov
Yasee Biomedical IncQINGDAO Shandong, ChinaContract manufacturer0000api.fda.gov

Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.