norav.comNR Recorder
Norav Medical GmbH
Norav Medical GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 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 | |
|---|---|---|---|
| 04260498564057 | Norav 1200 Series PC-ECG - 12 Lead ECG Cable with D15 type plug and Clip electrode connectors and build-in 10kOhm resistor | +4961345679830 | info@norav.com |
| 04260498566785 | Norav ECG Input Cable - Single ECG Lead for 1200W code: C1, IEC color with Clip connector | +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 |
| 200374 | 1508164476 | K120188 | ELECTROCARDIOGRAPH | DPS | 2012-03-16 |
| 200374 | 1334884139 | K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | MLO | 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 |
| 200374 | 1299563999 | K072446 | MOBIL-O-GRAPH NG 24 H ABP-CONTROL | DXN | 2007-11-29 |
| 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 |
Product Codes Associated With Registrations#
PMN#
GUDID#
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
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 - 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, Clip connectors, IEC color coding
2020-07-09
Norav 1200 Series PC-ECG - ECG Leadwire Set for 1200W with a Length of 1000mm, Clip connectors, AHA color coding
2020-07-09
Norav Medical - ECG Input Cable with Standard Sub-D Plug to 3 Leads with AHA color coded Clip connectors
2020-01-03
Norav ECG Input Cable - Single ECG Lead for 1200W code: C1, IEC color with Clip connector
2019-12-14
Norav ECG Input Cable - Single ECG Lead for 1200W code: C1, IEC color with Snap connector
2019-12-14
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 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 - "Extension Cable 3 Leads for ECG Input Cable ""C3-C-U-LL-ODUR"""
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, Ventri"""
2019-12-05
Norav Medical - ECG Input Cable with dedicated ODU Plug to 3 Leads with Clip connectors (Ventri)
2019-12-05
Norav Medical - ECG Leadwire Set for 1200W with Clip connectors, IEC color coding
2019-12-05
Norav Medical - ECG Leadwire Set for 1200W with Clip 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 Snap connectors, AHA 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, IEC color coding
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 Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectorsSpecial edition for GE Healthcare
2019-12-05
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 - ECG Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors
2018-09-18
Norav 1200 Series PC-ECG - PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labelling;Special edition for GE Health Care.
2020-07-09
Norav 1200 Series PC-ECG - PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labelling;Special edition for GE Health Care.
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
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 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 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 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 - 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), 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), 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 - 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 1200HRT (UDI: 04260498566815) 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.
2020-07-08
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.
2020-05-29
Norav 1200 Series - Single Channel ECG Acquisition Module for integration in other Medical Devices.Special edition for GE Health Care.
2020-05-29
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.
2020-03-31
Norav 1200 Series PC-ECG - Kit includes: PC-ECG 1200HRT (UDI: 04260498566815) for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG Trigger Output and IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors.
2020-01-03