Norav Medical GmbH

Address:Christof Ruthof Weg 10,Mainz-Kastel Hesse,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (9) Cable, Electrode (IKD) (1)

Premarket Exempt

No Yes

Clear

Norav 1200 Series PC-ECG - 04260498566853 Catalog Number : 1200HRT-K-00-U-S10-04

Device Description : Kit includes: PC-ECG 1200HRT (UDI: 04260498566815) for High Resolution Resting-E 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.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav NR Series - 04260498566860 Catalog Number : NR314T-K-00-U-S5-04

Device Description : Kit includes: Norav Telemetry ECG Recording Unit NR-314-T (UDI: 04260498565283) 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.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566877 Catalog Number : 1200HR-K-00-E-S10-04

Device Description : Kit includes: PC-ECG 1200HR (UDI: 04260498566822) for High Resolution Resting-EC 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.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series - 04260498566884 Catalog Number : ECGUSB1DEX-K-00-EC3-11

Device Description : Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) fo 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.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series - 04260498566891 Catalog Number : ECGUSB1DEX-D-00-11

Device Description : Single Channel ECG Acquisition Module for integration in other Medical Devices.S Single Channel ECG Acquisition Module for integration in other Medical Devices.Special edition for GE Health Care.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566907 Catalog Number : 1200WR-D-00-09

Device Description : Norav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566914 Catalog Number : 1200W2-K-04-E-C10-03

Device Description : Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.0 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.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566921 Catalog Number : 1200W2-K-04-U-C10-03

Device Description : Kit includes: PC-ECG 1200W (UDI: 04260498565054) wireless Stress-Test Kit (Rev.0 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.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566938 Catalog Number : 1200W2-K-04-U-C10-04

Device Description : Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.0 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.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav ECG Input Cable - 04260498566945 Catalog Number : LC1-S-E-W-07

Device Description : Single ECG Lead for 1200W code: C1, IEC color with Snap connector

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

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