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Data / Medical devices / Condenser, Heat And Moisture (Artificial Nose)

Condenser, Heat And Moisture (Artificial Nose) (BYD): 87 FDA-registered makers in 15 countries

87 establishments in 15 countries are registered with the FDA to make Condenser, Heat And Moisture (Artificial Nose) (product code BYD, Class 1, 21 CFR 868.5375). 8 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 73 510(k) clearances under this code, the latest on January 30, 1996, and lists 11 recall events (2 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.

Product code
BYD
Device class
1
Regulation
868.5375
Medical specialty
Anesthesiology

Makers by country

CountryMakers
China25
United States18
Taiwan12
Mexico7
United Kingdom6
Sweden4
Malaysia3
Germany3
Italy2
Lithuania2
Estonia1
Belarus1
Finland1
India1
Turkey1

Makers of Condenser, Heat And Moisture (Artificial Nose)

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
CovidienLafayette, CO, United StatesSpecification developer4June 8, 1995000api.fda.gov
Mallinckrodt Dar S.r.l.MIRANDOLA Modena, ItalyManufacturer4June 8, 1995000api.fda.gov
Pharma Systems ABLysekil Halland, SwedenManufacturer2November 9, 1990000api.fda.gov
Pharma Systems Eesti OURiidakula Hiiumaa, EstoniaManufacturer2November 9, 1990000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2June 12, 1995041api.fda.gov
Teleflex Medical Sdn. Bhd.KAMUNTING Perak, MalaysiaManufacturer2June 12, 1995000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1January 19, 1988000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer1January 19, 1988000api.fda.gov
AB UlaxMOTALA Ostergotland, SwedenManufacturer0010api.fda.gov
Amsino Medical (shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Asomedica Co. LtdSmolevichi District Minsk, BelarusManufacturer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesSpecification developer0000api.fda.gov
Atos Medical ABHORBY Skane, SwedenManufacturer0010api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandSpecification developer0000api.fda.gov
Biopsybell S.R.L.MIRANDOLA Modena, ItalyManufacturer0000api.fda.gov
Brightwake LtdKirkby-in-Ashfield Nottinghamshire, United KingdomManufacturer0000api.fda.gov
Bruce Medical SupplyWaltham, MA, United StatesManufacturer0000api.fda.gov
Besmed Health Business CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Create Biotech Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer0000api.fda.gov
Draeger Interservices GmbHLuebeck Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Draegerwerk AG & Co. KGaALUEBECK Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Dujo Logos Inc. DBA: MEDICOMP MEDICALPrinceton, MN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Eon Meditech Pvt. Ltd.Surat Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Excellentcare Medical (Huizhou) Ltd.Huizhou Guangdong, ChinaManufacturer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer0000api.fda.gov
Fogless International ABVaggeryd Jonkoping, SwedenManufacturer0000api.fda.gov
Foremount Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Freudenberg Medical, LLCCarpinteria, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Freudenberg Medical, LLCBaldwin Park, CA, United StatesContract manufacturer0000api.fda.gov
Galemed Corp.WU-JIA Yilan, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Great Group Medical Co Ltd.Changhua County, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
GVS Filter Technology UK LtdLancaster Lancashire, United KingdomManufacturer, Specification developer0000api.fda.gov
GVS Technology (Suzhou) Co., LtdSuzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
GaleMed (Xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Henan Tuoren Medical Device Co., Ltd.Changyuan Henan, ChinaManufacturer0000api.fda.gov
Hitec Medical Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
Innovatif Cekal Sdn BhdKlang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Intechrity IncIrvine, CA, United StatesContract manufacturer0000api.fda.gov
Intersurgical Ltd.Wokingham, Berkshire, United KingdomManufacturer, Specification developer0000api.fda.gov
IPE Plastic & Hardware Industy, LTDDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Intersurgical Inc.Indianapolis, IN, United StatesSpecification developer0000api.fda.gov
Intersurgical Medical Sdn. Bhd.Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Jiangxi Yiles Medical Co., LtdNanchang City Jiangxi, ChinaManufacturer0000api.fda.gov
King Systems Corporation.Noblesville, IN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Kung Shin Plastics Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Medease Life Co.,LtdDANYANG Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.Tire Izmir, TurkeyContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ningbo Boya Medical Equipment Co.,ltd.Yuyao Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ningbo Hanyue Medical Technology Co.,ltdCIXI CITY Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ningbo Huakun Medical Equipment Co.,ltdCixi Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Non-Change Enterprise Co., Ltd.New Taipei City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Passy-Muir, Inc.Irvine, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Pepper Medical, Inc.West Chester, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
S & Mohr America, S.A. DE C.V.ESTADO DE MEXICO Ciudad de Mexico, MexicoManufacturer0000api.fda.gov
Saykia CorporationChanghua County, TaiwanManufacturer0000api.fda.gov
Shandong Jinlai Huanhai Medical Technology Co.,ltdYantai Shandong, ChinaManufacturer0000api.fda.gov
Shaoxing Haitech Medical Products Co., LtdSHAOXING Zhejiang, ChinaManufacturer0000api.fda.gov
Shaoxing Jiancheng Medical Products Co., Ltd.Shaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Shaoxing Reborn Medical Devices Co.,ltdShaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Shaoxing Undis Medical Technology Company LimitedShaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Sheffmed LimitedRotherham, United KingdomManufacturer0000api.fda.gov
Shikani Medical LLCLutherville, MD, United StatesSpecification developer0000api.fda.gov
Somnetics International, IncFridley, MN, United StatesSpecification developer0000api.fda.gov
Sunmed Ap, Ltd.ZHUHAI Guangdong, ChinaContract manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Thermedia CorporationShelton, WA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tracoe Medical GMBHNIEDER-OLM Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer0000api.fda.gov
UAB IntersurgicalPABRADE Svencionys, LithuaniaContract manufacturer0000api.fda.gov
UAB IntersurgicalVisaginas Salcininkai, LithuaniaContract manufacturer0000api.fda.gov
VADI Medical Technology Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Vincent Medical (dong Guan) Manufacturing Co., Ltd.Dong Guan City Guangdong, ChinaContract manufacturer0000api.fda.gov
VR Medical Technology Co., Ltd.KUNSHAN Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
WESTMED de Mexico, S.A de C.V.Tecate Baja California, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Westmed Javid de Mexico, S.A. de C.V.NOGALES Sonora, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Runqiang Medical Instruments Co.,ltd.Jiaxing Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated January 30, 1996. 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.