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
| Country | Makers |
|---|---|
| China | 25 |
| United States | 18 |
| Taiwan | 12 |
| Mexico | 7 |
| United Kingdom | 6 |
| Sweden | 4 |
| Malaysia | 3 |
| Germany | 3 |
| Italy | 2 |
| Lithuania | 2 |
| Estonia | 1 |
| Belarus | 1 |
| Finland | 1 |
| India | 1 |
| Turkey | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Covidien | Lafayette, CO, United States | Specification developer | 4 | June 8, 1995 | 0 | 0 | 0 | api.fda.gov |
| Mallinckrodt Dar S.r.l. | MIRANDOLA Modena, Italy | Manufacturer | 4 | June 8, 1995 | 0 | 0 | 0 | api.fda.gov |
| Pharma Systems AB | Lysekil Halland, Sweden | Manufacturer | 2 | November 9, 1990 | 0 | 0 | 0 | api.fda.gov |
| Pharma Systems Eesti OU | Riidakula Hiiumaa, Estonia | Manufacturer | 2 | November 9, 1990 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | June 12, 1995 | 0 | 4 | 1 | api.fda.gov |
| Teleflex Medical Sdn. Bhd. | KAMUNTING Perak, Malaysia | Manufacturer | 2 | June 12, 1995 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | January 19, 1988 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | January 19, 1988 | 0 | 0 | 0 | api.fda.gov |
| AB Ulax | MOTALA Ostergotland, Sweden | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asomedica Co. Ltd | Smolevichi District Minsk, Belarus | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atos Medical AB | HORBY Skane, Sweden | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biopsybell S.R.L. | MIRANDOLA Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brightwake Ltd | Kirkby-in-Ashfield Nottinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bruce Medical Supply | Waltham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Create Biotech Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dujo Logos Inc. DBA: MEDICOMP MEDICAL | Princeton, MN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eon Meditech Pvt. Ltd. | Surat Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Excellentcare Medical (Huizhou) Ltd. | Huizhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical (dongguan) Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fogless International AB | Vaggeryd Jonkoping, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foremount Enterprise Co., Ltd. | Taichung City, Taiwan | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical, LLC | Carpinteria, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical, LLC | Baldwin Park, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galemed Corp. | WU-JIA Yilan, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Group Medical Co Ltd. | Changhua County, Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Nuoning Medical Supplies Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GVS Filter Technology UK Ltd | Lancaster Lancashire, United Kingdom | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GVS Technology (Suzhou) Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Tuoren Medical Device Co., Ltd. | Changyuan Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitec Medical Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hsiner Co., Ltd. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hsiner Co., Ltd. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovatif Cekal Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intechrity Inc | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Ltd. | Wokingham, Berkshire, United Kingdom | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IPE Plastic & Hardware Industy, LTD | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Inc. | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Medical Sdn. Bhd. | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Yiles Medical Co., Ltd | Nanchang City Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| King Systems Corporation. | Noblesville, IN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kung Shin Plastics Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medease Life Co.,Ltd | DANYANG Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. | Tire Izmir, Turkey | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Boya Medical Equipment Co.,ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Hanyue Medical Technology Co.,ltd | CIXI CITY Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Huakun Medical Equipment Co.,ltd | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo, Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Non-Change Enterprise Co., Ltd. | New Taipei City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Passy-Muir, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pepper Medical, Inc. | West Chester, PA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| S & Mohr America, S.A. DE C.V. | ESTADO DE MEXICO Ciudad de Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saykia Corporation | Changhua County, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Jinlai Huanhai Medical Technology Co.,ltd | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Haitech Medical Products Co., Ltd | SHAOXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Jiancheng Medical Products Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Reborn Medical Devices Co.,ltd | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheffmed Limited | Rotherham, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shikani Medical LLC | Lutherville, MD, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Somnetics International, Inc | Fridley, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunmed Ap, Ltd. | ZHUHAI Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermedia Corporation | Shelton, WA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tracoe Medical GMBH | NIEDER-OLM Rhineland-Palatinate, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | PABRADE Svencionys, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | Visaginas Salcininkai, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VADI Medical Technology Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vincent Medical (dong Guan) Manufacturing Co., Ltd. | Dong Guan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VR Medical Technology Co., Ltd. | KUNSHAN Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WESTMED de Mexico, S.A de C.V. | Tecate Baja California, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasco Enterprise Corp. | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Runqiang Medical Instruments Co.,ltd. | Jiaxing Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.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.