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) (6) Cable, Electrode (IKD) (4)

Premarket Exempt

No Yes

Clear

Norav Medical - 04260498563074 Catalog Number : C3-C-U-LL-D

Device Description : ECG Input Cable with 15-pin D-Sub Plug to 1.8m Trunk Cable and 1m Leads with Med 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

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Norav 1200 Series - 04260498564255 Catalog Number : ECGUSB1DEX-K-00-EC3-05

Device Description : Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) fo Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in other Medical Devices. ECG Input Cable, 3 leads, IEC color codingSpecial 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 - 04260498564262 Catalog Number : ECGUSB1DEX-D-00-08

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 ECG Input Cable - 04260498564293 Catalog Number : C3-C-E-ODU

Device Description : ECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Cl ECG Input Cable with dedicated ODU Plug with IEC color coding to 3 Leads with Clip connectors

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Norav - 04260498564309 Catalog Number : C3-C-U-ODU

Device Description : ECG Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Cl ECG Input Cable with dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Norav 1200 Series PC-ECG - 04260498565047 Catalog Number : 1200W2-D-04E-02

Device Description : PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labelling;S PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labelling;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 - 04260498565054 Catalog Number : 1200W2-D-04U-02

Device Description : PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labelling;S PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labelling;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 NR Series - 04260498565283 Catalog Number : NR314T-D-00U-04

Device Description : Norav Telemetry ECG Acquisition Device NR-314-T for Telemetry 3 Channel Resting- Norav Telemetry ECG Acquisition Device NR-314-T for Telemetry 3 Channel Resting-ECG Monitoring with AHA type labelling.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series - 04260498565856 Catalog Number : ECGUSB1DEX-K-00-06

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav Medical - 04260498565948 Catalog Number : C3-C-U-LL-ODUR

Device Description : ECG Input Cable with 10kOhm Resistors and dedicated ODU Plug with AHA color codi ECG Input Cable with 10kOhm Resistors and dedicated ODU Plug with AHA color coding to 3 Leads with Clip connectors

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

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