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 | |
|---|---|---|---|
| 04260498564293 | Norav ECG Input Cable - ECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Clip connectors | +4961345679830 | info@norav.com |
| 04260498564309 | Norav - ECG Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors | +4961345679830 | info@norav.com |
| 04260498566266 | Norav Medical - ECG Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors | +4961345679830 | 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 - ECG Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors
2018-09-18
Norav ECG Input Cable - ECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Clip connectors
2019-01-26
Norav Medical - ECG Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectorsSpecial edition for GE Healthcare
2019-12-05
Norav Medical - ECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Clip connectorsSpecial edition for GE Healthcare
2019-12-05
Norav Medical - ECG Leadwire Set for 1200W with Snap connectors, IEC color coding
2019-12-05
Norav Medical - ECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Clip connectors
2019-12-05
Norav Medical - ECG Leadwire Set for 1200W with Snap connectors, AHA color coding
2019-12-05
Norav Medical - ECG Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors
2019-12-05
Norav Medical - ECG Leadwire Set for 1200W with Clip connectors, AHA color coding
2019-12-05
Norav Medical - ECG Leadwire Set for 1200W with Clip connectors, IEC color coding
2019-12-05
Norav Medical - ECG Input Cable with dedicated ODU Plug to 3 Leads with Clip connectors (Ventri)
2019-12-05
Norav Medical - "Extension Cable 3 Leads for ECG Input Cable ""C3-C-U-LL-ODUR, Ventri"""
2019-12-05
Norav Medical - ECG Input Cable White with 10kOhm Resistors and dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors
2019-12-05
Norav Medical - "Extension Cable 3 Leads for ECG Input Cable ""C3-C-U-LL-ODUR"""
2019-12-05
Norav Medical - ECG Input Cable with 10kOhm Resistors and dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors
2019-12-05
Norav Medical - ECG Input Cable with 15-pin D-Sub Plug to 1.8m Trunk Cable and 1m Leads with Medi-Clip, AHA color coding (RA-White, LL-Red, RL-Green)Special Edition for GE Health Care
2019-12-05
Norav ECG Input Cable - Single ECG Lead for 1200W code: C1, IEC color with Snap connector
2019-12-14
Norav ECG Input Cable - Single ECG Lead for 1200W code: C1, IEC color with Clip connector
2019-12-14
Norav Medical - ECG Input Cable with Standard Sub-D Plug to 3 Leads with AHA color coded Clip connectors
2020-01-03
Norav 1200 Series PC-ECG - ECG Leadwire Set for 1200W with a Length of 1000mm, Clip connectors, AHA color coding
2020-07-09
Norav 1200 Series PC-ECG - ECG Leadwire Set for 1200W with a Length of 1000mm, Clip connectors, IEC color coding
2020-07-09
Norav 1200 Series PC-ECG - ECG Leadwire Set for 1200W with a Length of 1000mm, Snap connectors, IEC color coding
2020-07-09
Norav 1200 Series PC-ECG - ECG Leadwire Set for 1200W with a Length of 1000mm, Snap connectors, AHA color coding
2020-07-09
Norav 1200 Series PC-ECG - 12 Lead ECG Cable with D15 type plug and Clip electrode connectors and build-in 10kOhm resistor
2023-02-18
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
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
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
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
"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
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 - 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 - Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integration in other Medical Devices. ECG Input Cable, 3 leads, IEC color coding Software Package on CDSpecial edition for GE Health Care.
2020-07-09
Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200W (UDI: 04260498565054) wireless Stress-Test Kit (Rev.02), GE-Service; PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads AHA type and Clip connectors.Special edition for GE Health Care.
2020-07-09
Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.02), GE-Service; PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads IEC type and Clip connectors.Special edition for GE Health Care.
2020-07-09
Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200W (UDI: 04260498565054) wireless Stress-Test Kit (Rev.02); PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads AHA type and Clip connectors.Special edition for GE Health Care.
2020-07-09
Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.02); PC-ECG 1200WR (UDI: 04260498566907) Receiver Unit Input cable with ten leads IEC type and Clip connectors.Special edition for GE Health Care.
2020-07-09
Norav 1200 Series PC-ECG - Norav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output.
2020-07-09
Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200HR (UDI: 04260498566822) for High Resolution Resting-ECG and Stress-Test ECG recordings with IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors.
2020-07-09
Norav NR Series - Kit includes: Norav Telemetry ECG Recording Unit NR-314-T (UDI: 04260498565283) for 3 Channel ECG Telemetry with AHA type labelling; Input cable with 4 Patient leads AHA type and Snap connectors.
2020-07-09
Norav NR Series - Norav Telemetry ECG Acquisition Device NR-314-T for Telemetry 3 Channel Resting-ECG Monitoring with AHA type labelling.
2020-07-09