Skip to content

Devices Categories Manufacturers Importers Certifiers Authorities Reps. Representatives

Results for “HeartR”

Name, manufacturer or identifier

Manufacturer (optional)

Filters

Registry EUDAMED 88 FDA 510(k) incl. De Novo 10 FDA PMA GUDID 72

Country / market European Union (all) 88 United States 82

More countries (11)

Austria 75 Czechia 3 Belgium 2 Bulgaria 1 Cyprus 1 Germany 1 Greece 1 Finland 1 France 1 Croatia 1 Ireland 1

Risk class Class I Class IIa Class IIb Class III 88 Class II (US) 82

More classes (11)

Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

Verified Verified only

Category (EMDN)

Browse by category

170 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Heartrak Af

Universal Medical, Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
Heartrak

Universal Medical, Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
HeartR

LifeTech Scientific (Europe) B.V.,Netherlands Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:III

Showing 101-120 of 170

deviCERTS Global Medical Device Regulatory Database

About [email protected]

© 2026 deviCERTS — digitaly.site