Data / Medical devices / Recorder, Magnetic Tape, Medical
Recorder, Magnetic Tape, Medical (DSH): 47 FDA-registered makers in 13 countries
47 establishments in 13 countries are registered with the FDA to make Recorder, Magnetic Tape, Medical (product code DSH, Class 2, 21 CFR 870.2800). 30 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 194 510(k) clearances under this code, the latest on July 9, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DSH
- Device class
- 2
- Regulation
- 870.2800
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 25 |
| Germany | 5 |
| China | 4 |
| South Korea | 3 |
| Canada | 2 |
| Singapore | 1 |
| Ireland | 1 |
| Switzerland | 1 |
| Spain | 1 |
| Vietnam | 1 |
| Malaysia | 1 |
| Slovakia | 1 |
| Mexico | 1 |
Makers of Recorder, Magnetic Tape, Medical
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 |
|---|---|---|---|---|---|---|---|---|
| Biox Instruments Co Ltd | Wuxi Jiangsu, China | Manufacturer | 4 | June 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cardiocomm Solutions, Inc. | North York Ontario, Canada | Complaint file establishment, Exporter to the US, Manufacturer | 4 | October 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| Irhythm Technologies, Inc. | San Francisco, CA, United States | Specification developer | 3 | August 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| dms-service llc | Los Angeles, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 3 | February 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| iRhythm Technologies, Inc. | Cypress, CA, United States | Manufacturer | 3 | August 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aevice Health Pte. Ltd. | Singapore North East, Singapore | Complaint file establishment, Manufacturer, Specification developer | 2 | May 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biotricity | Redwood City, CA, United States | Manufacturer | 2 | July 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Scottcare Corporation | Cleveland, OH, United States | Manufacturer | 2 | October 24, 2002 | 0 | 0 | 0 | api.fda.gov |
| Strados Labs Inc. | Marietta, GA, United States | Manufacturer | 2 | April 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Vitalograph Ireland Ltd. | Co Clare, Ireland | Manufacturer | 2 | December 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| ATsens Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | May 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bardy Diagnostics, Inc. | Bellevue, WA, United States | Specification developer | 1 | November 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Braemar Manufacturing, LLC | Eagan, MN, United States | Complaint file establishment, Manufacturer | 1 | January 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Braemar Manufacturing, LLC | San Diego, CA, United States | Specification developer | 1 | January 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cardiac Insight, Inc. | Bellevue, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Cardionet, LLC | Phoenix, AZ, United States | Complaint file establishment, Contract manufacturer | 1 | January 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cardionet, LLC | Linwood, PA, United States | Complaint file establishment, Contract manufacturer | 1 | January 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 1 | September 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Global Instrumentation, LLC | E Syracuse, NY, United States | Manufacturer | 1 | December 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| ICENTIA Inc | Quebec, Canada | Manufacturer | 1 | March 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Peerbridge Health, Inc. | Franklin, TN, United States | Manufacturer, Specification developer | 1 | September 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| R & D Batteries, Inc. | Burnsville, MN, United States | Manufacturer | 1 | December 3, 1993 | 0 | 0 | 0 | api.fda.gov |
| Schiller AG | BAAR Zug, Switzerland | Manufacturer | 1 | April 6, 2007 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Creative Industry Co., Ltd | SHENZHEN Guangdong, China | Manufacturer | 1 | January 10, 2008 | 0 | 0 | 0 | api.fda.gov |
| Smart Solutions Technologies S.L. (nuubo) | madrid Madrid(Province), Spain | Manufacturer | 1 | August 3, 2018 | 0 | 0 | 0 | api.fda.gov |
| Somnomedics AG | RANDERSACKER Bavaria, Germany | Manufacturer | 1 | November 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Wearlinq | Rockville, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Specification developer | 1 | August 24, 2005 | 0 | 0 | 0 | api.fda.gov |
| Wellysis Corp. | Gangnam-gu, Seoul, South Korea | Manufacturer | 1 | August 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| eResearchTechnology GmbH | Estenfeld Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | June 10, 2009 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Sylmar, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bernd Richter GMBH | Wipperfuerth North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cal-Comp Usa | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreamtech Co., Ltd. | Asan-si Chungnam, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreamtech Vietnam Co., Ltd | Tu Son Ward Bac Ninh, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iot Manufacturing Sdn. Bhd. | PASIR GUDANG Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Export, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qualitel Corporation | Everett, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Semecs, S.R.O. | Vrable Nitriansky, Slovakia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn De Mexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 9, 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.