norav.comNR Recorder
Norav Medical GmbH
NORAV MEDICAL LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9681548 | 3002807745 | NORAV MEDICAL LTD. | 1 | N | 2026-01-01 | 4 HAMADA ST. YOKNEAM Northern IL 20692 |
| 3008977358 | 3008977358 | Norav Medical Inc. | 1 | Y | 2026-01-01 | 1300 Wallace Dr Delray Beach FL US 33444 |
| 3013298536 | 3013298536 | Norav Medical GmbH | 1 | N | 2020-04-25 | Christof Ruthof Weg 10 Mainz-Kastel Hessen DE 55252 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290110250591 | Receiver for 1200W with ECG trigger (TTL) output - PC-ECG Wireless Receiver Device for Stress-Test ECG.The 1200WR is the Digital RF Receiver unit of the PC-ECG 1200W System. | +97249893001 | info@norav.com |
| 07290110251062 | ECG - The ECG-USB1 device provides a single channel ECG for host systems that require an external unit in order to add ECGRespiration capabilities in an easy and fast way to their platform. The host owner should write its own software application that communicates with the device via USB port using the Norav USB driver and SDK. | +97249893001 | support@norav.com |
| 07290110251192 | Telemetry System. License + Software for up to 7 users - The NM-700 model, which is part of the PCECG1200 system, is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. | +97249893001 | info@norav.com |
| 07290110252502 | Norav 1200 Series PC-ECG - "Mobile PC-ECG 1200 System for Resting-ECG, based on an All-in-One-PC with 21"" Touch Screen, rechargeable Battery and built-in ECG Acquisition Unit." | +97249893001 | info@norav.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 200374 | 1584374873 | K161062 | NR Recorder | MWJ | 2016-06-13 |
| 134275 | 1584374873 | K161062 | NR Recorder | MWJ | 2016-06-13 |
| 200374 | 1508164476 | K120188 | ELECTROCARDIOGRAPH | DPS | 2012-03-16 |
| 200374 | 1334884139 | K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | MLO | 2011-11-10 |
| 134275 | 1334884139 | K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | MLO | 2011-11-10 |
| 134275 | 1859355806 | K110463 | PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) | MWI | 2011-11-10 |
| 200374 | 1859355806 | K110463 | PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) | MWI | 2011-11-10 |
| 200374 | 1788834213 | K080141 | PC ECG 1200W SYSTEM | MWI | 2008-04-25 |
| 134275 | 1788834213 | K080141 | PC ECG 1200W SYSTEM | MWI | 2008-04-25 |
| 200374 | 1299563999 | K072446 | MOBIL-O-GRAPH NG 24 H ABP-CONTROL | DXN | 2007-11-29 |
| 134275 | 1736719099 | K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | MLO | 2002-05-08 |
| 200374 | 1736719099 | K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | MLO | 2002-05-08 |
| 200374 | 1571583339 | K000404 | PC ECG 1200 | MWI | 2000-11-22 |
| 134275 | 1571583339 | K000404 | PC ECG 1200 | MWI | 2000-11-22 |
| 16284 | 1571583339 | K000404 | PC ECG 1200 | MWI | 2000-11-22 |
| 16284 | 1334884139 | ||||
| 16284 | 1584374873 | ||||
| 16284 | 1736719099 | ||||
| 16284 | 1788834213 | ||||
| 16284 | 1859355806 |
Product Codes Associated With Registrations#
PMN#
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
NORAV MEDICAL CORP.
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
NORAV MEDICAL LTD.
PC ECG 1200W SYSTEM
NORAV MEDICAL LTD.
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
NORAV MEDICAL LTD.
PC ECG 1200
NORAV MEDICAL LTD.
GUDID#
Norav 1200 Series PC-ECG - PC-ECG Wireless Receiver Device for Stress-Test ECG.The 1200WR is the Digital RF Receiver unit of the PC-ECG 1200W System.Special edition for GE Health Care.
2019-09-27
Receiver for 1200W with ECG trigger (TTL) output - PC-ECG Wireless Receiver Device for Stress-Test ECG.The 1200WR is the Digital RF Receiver unit of the PC-ECG 1200W System.
2016-10-26
Telemetry System. License + Software for up to 7 users - The NM-700 model, which is part of the PCECG1200 system, is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value.
2017-01-03
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Driver for P-MP200 Thermal Printer The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-02
Norav 1200 Series PC-ECG - "Mobile PC-ECG 1200 System for Resting-ECG, based on an All-in-One-PC with 21"" Touch Screen, rechargeable Battery and built-in ECG Acquisition Unit."
2019-09-30
"ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3"" prin" - "Mobile PC-ECG 1200 System for Resting-ECG, based on an All-in-One-PC with 21"" Touch Screen, rechargeable Battery and built-in ECG Acquisition Unit."
2017-01-03
ECG - The ECG-USB1 device provides a single channel ECG for host systems that require an external unit in order to add ECGRespiration capabilities in an easy and fast way to their platform. The host owner should write its own software application that communicates with the device via USB port using the Norav USB driver and SDK.
2016-10-13
Norav 1200 Series PC-ECG - Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110255572), R2, NV, FW11, for integration in other Medical Devices; Input cable with three Patient Leads IEC type with Clip connectors.Special edition for GE Health Care.
2020-06-05
Norav 1200 Series PC-ECG - Single Channel ECG Acquisition Module for integration in other Medical Devices.Add On ECG 1Ch Acq.Device NV FW11BSpecial edition for GE Health Care.
2020-06-05
Norav 1200 Series PC-ECG - Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110255572), R2, NV, FW11, for integration in other Medical Devices; Input cable with three Patient Leads IEC type with Clip connectors.Special edition for GE Health Care.
2020-06-05
Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200HR (UDI: 07290110255497) for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG-Trigger Output and AHA type labelling. Input cable with 10 Patient leads AHA type and Snap connectors.
2020-06-03
Norav 1200 Series PC-ECG - PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG-Trigger Output and AHA type labelling.
2020-06-03
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I3 = Resting-ECG Measurement and MEANS Analysis ECG Measurements & Expert System, The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-11
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-02
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-02
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Upgrade Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-02
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I1 = Restin-ECG Measurement The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-02
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I1 = Resting-ECG Measurement - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-02
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I3 = Resting-ECG Measurement and Interpretation MEANS (Uni. of Rotterdam, NL) - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-02
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-02
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit (COSMED) with the following Option(s): - D1 = ECG Management System NEMS - S2 = Advanced Stress-Test ECG - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-01
Norav 1200 Series PC-ECG - "Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - ""HASP-Key"" Software on Installation Medium (CD or USB-Stick)."
2019-10-01
Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200T; Operating voltage 5V with Trigger (Analogue) from selectable channel (UDI: 07290110255473) Input Cable with 3 Patient Leads AHA Type and Clip Connectors
2019-12-20
Norav 1200 Series PC-ECG - PC-ECG 1200T Acqusition Device with Trigger and selectable channel, 5V operating voltage.
2019-12-20
Norav NR Series - Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 7290110253073) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., max. 7days and IEC type labelling; Input cable with 10 Patient leads IEC type and Snap connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors. Input cable with 5 Patient leads IEC type and Snap connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254698) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., max. 7days and IEC type labelling; Input cable with 10 Patient leads IEC type and Snap connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254711) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., max. 7days and AHA type labelling; Input cable with 10 Patient leads AHA type and Snap connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254759) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110254766) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254773) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors. Input cable with 5 Patient leads IEC type and Snap connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110254889) for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors. Input cable with 5 Patient leads AHA type and Snap connectors.
2019-10-01
Norav NR Series - Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling.Special edition for TASHIO
2019-10-01
Norav NR Series - Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.Special edition for TASHIO
2019-10-01
Norav NR Series - Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.Special edition for TASHIO
2019-10-01
Norav NR Series - Kit includes: Norav Wireless ECG Acquisition Device NR3 (UDI: 7290110255381) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors.
2019-10-01
Norav NR Series - Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channels, max. 48h recording capacity and IEC type labelling.
2019-09-30