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Data / Medical devices / Bottle, Hot/Cold Water

Bottle, Hot/Cold Water (FPF): 46 FDA-registered makers in 7 countries

46 establishments in 7 countries are registered with the FDA to make Bottle, Hot/Cold Water (product code FPF, Class 1, 21 CFR 880.6085). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 30, 1979, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FPF
Device class
1
Regulation
880.6085
Medical specialty
General Hospital

Makers by country

CountryMakers
China26
United States10
Taiwan4
India3
Pakistan1
Israel1
Bangladesh1

Makers of Bottle, Hot/Cold Water

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
Huntex CorporationTaipei, TaiwanManufacturer1July 30, 1979000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Apothecary Products, LLC.Burnsville, MN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ameda, Inc.Austin, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bruder Healthcare CompanyFairfield, OH, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Capital Sports Corporation (pvt) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
China Medilife Products Co., Ltd.YANGZHOU Jiangsu, ChinaContract manufacturer, Exporter to the US, Repackager or relabeler0000api.fda.gov
Du-Hope International GroupNANJING Jiangsu, ChinaManufacturer0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Euroband Bioline LTD.INDUSTRIAL PARK EMEK HEFER Central, IsraelSpecification developer0000api.fda.gov
Fabrication Ent., Inc.Elmsford, NY, United StatesManufacturer0000api.fda.gov
Global TV Concepts, Ltd.Coconut Creek, FL, United StatesSpecification developer0000api.fda.gov
Guangdong Yinghai Industrial Technology Co., LtdZHONGSHAN Guangdong, ChinaManufacturer0000api.fda.gov
Hong Ming Enterprise Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Hubei Xinyunqi Household Products Co., Ltd.Tongshan Hubei, ChinaManufacturer0000api.fda.gov
Huizhou Hizorion Tech Co.,ltdHuizhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Jiangsu Senwo Medical Technology Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangsu World Biotech Co., Ltdnantong Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Yishun Medical Equipment Co., LtdNantong Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Nanjing Asn Medical Technology Co.,ltdNANJING Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nantong Haochuan Industry Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Ningbo High-Tech Bluesky Manufactory And Trading Co.,ltd.NINGBO Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ninghai Shengyue Electrical Appliance Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Novex Innovations, LLCWinston Salem, NC, United StatesManufacturer0000api.fda.gov
Neonatal Product Group, Inc.Overland Park, KS, United StatesManufacturer0000api.fda.gov
R&R Medical Corporation Ltd.Sanchong District New Taipei, TaiwanManufacturer0000api.fda.gov
Shun Ho (bangladesh) Manufactory LimitedCumilla Zilla Chittagong(Division), BangladeshContract manufacturer0000api.fda.gov
Shun Sze Industrial (shenzhen) Co., LtdSHENZHEN Guangdong, ChinaContract manufacturer0000api.fda.gov
Suzhou Pipi Medical Products Co.,ltdSuzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shijiazhuang Aofeite Medical Device Co.,LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Suzhou Meccan Import and Export Corp.Suzhou Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tops Medical Articles Industries Nantong IncQidong City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Welbreath Technology Co.,ltdbaoding Hebei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Wenzhou Longwan Medical Device FactoryWenzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Wenzhou Kangju Medical Instrument Co., Ltd.Wenzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaManufacturer0000api.fda.gov

Updated July 30, 1979. 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.