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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

CountryMakers
United States25
Germany5
China4
South Korea3
Canada2
Singapore1
Ireland1
Switzerland1
Spain1
Vietnam1
Malaysia1
Slovakia1
Mexico1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biox Instruments Co LtdWuxi Jiangsu, ChinaManufacturer4June 28, 2011000api.fda.gov
Cardiocomm Solutions, Inc.North York Ontario, CanadaComplaint file establishment, Exporter to the US, Manufacturer4October 7, 2011000api.fda.gov
Irhythm Technologies, Inc.San Francisco, CA, United StatesSpecification developer3August 15, 2025000api.fda.gov
dms-service llcLos Angeles, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3February 22, 2017000api.fda.gov
iRhythm Technologies, Inc.Cypress, CA, United StatesManufacturer3August 15, 2025000api.fda.gov
Aevice Health Pte. Ltd.Singapore North East, SingaporeComplaint file establishment, Manufacturer, Specification developer2May 5, 2025000api.fda.gov
BiotricityRedwood City, CA, United StatesManufacturer2July 29, 2020000api.fda.gov
Scottcare CorporationCleveland, OH, United StatesManufacturer2October 24, 2002000api.fda.gov
Strados Labs Inc.Marietta, GA, United StatesManufacturer2April 27, 2022000api.fda.gov
Vitalograph Ireland Ltd.Co Clare, IrelandManufacturer2December 3, 2025000api.fda.gov
ATsens Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer1May 2, 2025000api.fda.gov
Bardy Diagnostics, Inc.Bellevue, WA, United StatesSpecification developer1November 22, 2023000api.fda.gov
Braemar Manufacturing, LLCEagan, MN, United StatesComplaint file establishment, Manufacturer1January 4, 2018000api.fda.gov
Braemar Manufacturing, LLCSan Diego, CA, United StatesSpecification developer1January 4, 2018000api.fda.gov
Cardiac Insight, Inc.Bellevue, WA, United StatesComplaint file establishment, Manufacturer, Specification developer1March 24, 2017000api.fda.gov
Cardionet, LLCPhoenix, AZ, United StatesComplaint file establishment, Contract manufacturer1January 4, 2018000api.fda.gov
Cardionet, LLCLinwood, PA, United StatesComplaint file establishment, Contract manufacturer1January 4, 2018000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer1September 25, 2023000api.fda.gov
Global Instrumentation, LLCE Syracuse, NY, United StatesManufacturer1December 29, 2020000api.fda.gov
ICENTIA IncQuebec, CanadaManufacturer1March 22, 2023000api.fda.gov
Peerbridge Health, Inc.Franklin, TN, United StatesManufacturer, Specification developer1September 27, 2017000api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer1December 3, 1993000api.fda.gov
Schiller AGBAAR Zug, SwitzerlandManufacturer1April 6, 2007000api.fda.gov
Shenzhen Creative Industry Co., LtdSHENZHEN Guangdong, ChinaManufacturer1January 10, 2008000api.fda.gov
Smart Solutions Technologies S.L. (nuubo)madrid Madrid(Province), SpainManufacturer1August 3, 2018000api.fda.gov
Somnomedics AGRANDERSACKER Bavaria, GermanyManufacturer1November 27, 2023000api.fda.gov
WearlinqRockville, MD, United StatesComplaint file establishment, Manufacturer, Specification developer1October 20, 2022000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer1August 24, 2005000api.fda.gov
Wellysis Corp.Gangnam-gu, Seoul, South KoreaManufacturer1August 30, 2023000api.fda.gov
eResearchTechnology GmbHEstenfeld Bavaria, GermanyComplaint file establishment, Manufacturer1June 10, 2009000api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Bernd Richter GMBHWipperfuerth North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Cal-Comp UsaCarlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Dreamtech Co., Ltd.Asan-si Chungnam, South KoreaContract manufacturer0000api.fda.gov
Dreamtech Vietnam Co., LtdTu Son Ward Bac Ninh, VietnamContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Iot Manufacturing Sdn. Bhd.PASIR GUDANG Johor, MalaysiaContract manufacturer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Qualitel CorporationEverett, WA, United StatesContract manufacturer0000api.fda.gov
Semecs, S.R.O.Vrable Nitriansky, SlovakiaContract manufacturer0000api.fda.gov
Welch Allyn De Mexico, S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.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.