Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

VASOMEDICAL, INC.

United States·US-MF-000030121

Last updated September 17, 2026

Information

Country
United States
Address
137 Commercial Street,Suite 200 Plainview, New York, United States
LinkedIn
—
Facebook
—
Phone
+1(516)508-5818
PRRC Contact
Hong Chen
EUDAMED SRN
US-MF-000030121
FDA FEI Number
2435300
DUNS Number
197210248

Catalogue (153)

Page 3 of 4
DeviceModel / ReferenceRegistriesClassStatus
Vasomedical-Biox™ Model 1305 3 CH Recorder - 5 Lead Patient Cable Model 1305 Kit
FDA UDI
Class IIActive
ECG Cable Adaptor-for use with V10-0017 (Model TS3) Model TS3
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 1201 3 CH Mini ECG Recorder Model 1201 Kit
FDA UDI
Class IIActive
Vasomedical™ AngioNew -VI EECP® Therapy System Model AngioNew VI
FDA UDI
Class IIActive
Patient Stop Cable (Model TS4 and Lumenair™) Model Lumenair
FDA UDI
Class IIActive
Bladder Set, Medium Model Lumenair
FDA UDI
Class IIActive
TwiLoK™ Cuff Side Hose Connector Model Lumenair
FDA UDI
Class IIActive
Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG & ABP CB Series S/W
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 1303 3 CH ULTRA Recorder w/LCD - 7 Lead Patient Cable Model 1303 Kit
FDA UDI
Class IIActive
Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200/1201 2 & 3 CH ECG, USB ARCS Series S/W
FDA UDI
Class IIActive
Vasomedical-Biox™ 2306 Combined 12 CH ECG Holter & ABP Monitor with Bluetooth Model 2306
FDA UDI
Class IIActive
Treatment Pants, Medium Model Lumenair
FDA UDI
Class IIActive
Bladder Set, X-Large (should be used with XL and XXL cuffs) Model Lumenair
FDA UDI
Class IIActive
Treatment Pants, X-Large Model Lumenair
FDA UDI
Class IIActive
Infared Communication Adaptor Model 1805
FDA UDI
Class IIActive
Patient Stop Cable (AngioNew® V and VI) Model AngioNew VI
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 1304 12 CH Recorder - 10 Lead Patient Cable Model 1304 Kit
FDA UDI
Class IIActive
Nu Prep Gel, 4 oz (3 PK) Model Lumenair
FDA UDI
Class IIActive
Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W Model 1806
FDA UDI
Class IIActive
3-Ch ECG Holter Patient Cable w/5 Leads Model 1303
FDA UDI
Class IIActive
Spo2 Probe (Older AngioNew® V and VI) Model AngioNew VI
FDA UDI
Class IIActive
Hose, Set of 6 (Lumenair™) Model Lumenair
FDA UDI
Class IIActive
Adult BP Cuff (standard) 24-32cm Model 1805
FDA UDI
Class IIActive
Signa Electrode Gel, 2 oz Model Lumenair
FDA UDI
Class IIActive
Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth Model 1807
FDA UDI
Class IIActive
Vasomedical™ EZ™ ECG Monitor Model EZ
FDA UDI
Class IIActive
Vasomedical™ AngioNew -V EECP® Therapy System Model AngioNew V
FDA UDI
Class IIActive
Electrodes (600 per case) Model Lumenair
FDA UDI
Class IIActive
Treatment Pants, XX-Large Model Lumenair
FDA UDI
Class IIActive
Vasomedical™ EZ™ O2 Neonatal Probe (for children under 3 years of age) Model EZ
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 1806 Ambulatory Blood Pressure Recorder Model 1806 Kit
FDA UDI
Class IIActive
Portable Case w/Belt for 1303 Recorder Model 1303
FDA UDI
Class IIActive
Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG CB Series S/W
FDA UDI
Class IIActive
Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor Model 2301
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 1200 2 CH Mini ECG Recorder Model 1200 Kit
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 1306 12 CH Recorder - 10 Lead Patient Cable Model 1306 Kit
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 2306 12 CH/ABP COMB Recorder w/Bluetooth Model 2306 Kit
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 2304 12 CH/ABP COMB Recorder Model 2304 Kit
FDA UDI
Class IIActive
Cuff Set, XX-Large Model Lumenair
FDA UDI
Class IIActive
Vasomedical-Biox™ Model 1308 12 CH ULTRA Recorder w/Bluetooth Model 1308 Kit
FDA UDI
Class IIActive
Vasomedical-Biox™ CB Series Analysis & Reporting S/w - 3 & 12 CH ECG & ABP CB Series S/W
FDA UDI
Class IIActive
Thigh Cuff, X-Small Model Lumenair
FDA UDI
Class IIActive
Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP Monitor 04.23.03.0001
EUDAMEDFDA UDI
Class IIaActive
Eecp Therapy System, Model Ts3 K003469
FDA 510(k)
Class IIActive
Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301 K092785
FDA 510(k)
Class IIActive
Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox 3- Channel Miniature Ambulatory K111180
FDA 510(k)
Class IIActive
Vasomedical-Biox Combined 12 Channel Ambulatory Ecg And Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory K111096
FDA 510(k)
Class IIActive
Vasomedical Biox Cb-1305-C, 3 Channel Ecg Holter Monitor, Model Cb-1305-C K083820
FDA 510(k)
Class IIActive
Eecp Therapy System Model Ts4 With/Without Pluse Oximetry K033617
FDA 510(k)
Class IIActive
Eecp Therapy System Model Ts3 With Pulse Oximetry And Enhanced External Counterpulsation Eecp Mc-2 External Counter K020857
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.