Norav Medical GmbH
DE-MF-000006715 · Germany · Mainz-Kastel
Norav Medical GmbH is registered in the European database on medical devices as a manufacturer, with 250 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 250 |
|---|
Most frequent device types declared: Accessories, NR Series Ambulatory-ECG, NR Series ECG-Recorders, NR Series Telemetry-ECG, PC-ECG 1200 Series.
Among these devices, 203 are declared reusable, 47 active, 12 with a measuring function.
Devices declared under this manufacturer
- C-1200M-RS232
- C-1200S-USB
- C10-B-E-D-02
- C10-B-E-D-04
- C3-C-U-LL-ODUR-W
- C7-S-U-EI-07
- ECG-USB1 (EX)
- L10-S-E-W-08
- L10-S-U-W-07
- LN-C-E-W-07
- NR-314-P
- PC-ECG 1200S
Showing 12 of 250 declared devices.
Catalogue references include 1200S-D-00U-02, C-1200M-RS232, C-1200S-USB, C10-B-E-D-04, C7-S-U-EI-07, ECGUSB1DEX-D-00-01.
European nomenclature codes declared: Z12050380, Z12050101, Z12050403, Z12050192, Z12050301, Z12050302.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NORAV MEDICAL LTD. (IL) · FDA 9681548 |
| Devices in EUDAMED | 250 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 250 |
|---|---|
| Found in the U.S. device database | 27 |
| Share | 10.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NORAV MEDICAL LTD |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| First licensed | 2003-10-23 |
Licence types: Device Family (4), Single Device (2), Device Group Family (1), System (1).
Licensed under: PC-ECG 1200, NORAV HOLTER NH-300 SOFTWARE, NH-301 AMBULATORY ECG ANALYSIS SOFTWARE, CARDIOGRAPH PATIENT CABLES, PC-ECG 1200 (SOFTWARE), ECG LEADWIRES.
North American profile: Both markets. Norav Medical GmbH is registered in both the United States and Canada.