Norav Medical GmbH

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

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Filters

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

Cable, Electrode (IKD) (4) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (2)

Premarket Exempt

No Yes

Clear

Norav 1200 Series PC-ECG - 04260498566952 Catalog Number : 1200W2-K-04-U-C10-04

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), 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.

Device Class : 2

Duns Number: 341318999

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566969 Catalog Number : L10-S-U-W-L1-07

Device Description : ECG Leadwire Set for 1200W with a Length of 1000mm, Snap connectors, AHA color coding

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566976 Catalog Number : L10-S-E-W-L1-07

Device Description : ECG Leadwire Set for 1200W with a Length of 1000mm, Snap connectors, IEC color coding

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566983 Catalog Number : L10-C-E-W-L1-07

Device Description : ECG Leadwire Set for 1200W with a Length of 1000mm, Clip connectors, IEC color coding

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Norav 1200 Series PC-ECG - 04260498566990 Catalog Number : L10-C-U-W-L1-07

Device Description : ECG Leadwire Set for 1200W with a Length of 1000mm, Clip connectors, AHA color coding

Device Class : 2

Duns Number: 341318999

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Norav 1200 Series - 04260498567003 Catalog Number : ECGUSB1DEX-K-00-EC3-12

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

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