NORAS MRI products GmbH
DE-MF-000006182 · Germany · Höchberg
NORAS MRI products GmbH is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 29 |
|---|
Among these devices, 4 are declared reusable, 26 active.
Devices declared under this manufacturer
- BI 6 Comfort 3T
- Breast BI 7 MR Coil Set 1.5T
- Breast BI Coil Set 0.55T
- Cranio-caudal fixation unit CC-GE
- Encompass 15 Channel MRI Head Coil - 3T
- Mandibula 15-Channel Dental Coil 1.5T
- Mandibula 15-Channel Dental Coil 3T
- NORAS OR HEAD COIL Top Array Philips 1.5T
- NORAS OR HEAD COIL Top Array Philips 3T
- OR Head Holder LUCY with HeadCoilSet Philips 3T
- OR Head Holder LUCY with HeadCoilSet Siemens 1.5T
- OR Head Holder LUCY with HeadCoilSet Siemens 3T
Showing 12 of 29 declared devices.
Catalogue references include 111921, 114557, 114744, 118231, 119734, 119736.
European nomenclature codes declared: Z11059099, Z11059080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NORAS MRI products GMBH (DE) · FDA 3004929307 |
| Devices in EUDAMED | 29 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 29 |
|---|---|
| Found in the U.S. device database | 25 |
| Share | 86.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NORAS MRI PRODUCTS GMBH |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 2009-09-29 |
Licence types: Single Device (4), Device Family (2), System (1).
Licensed under: NORAS OR HEAD COIL 1.5T/3T, NORAS OR HEAD HOLDER, NORAS 4-CHANNEL BREAST COIL 3T, NORAS 4-CHANNEL BREAST COIL 1.5T, OR HEAD HOLDER FLEXIBILITY & OR HEAD COIL SET, VARIETY 16-CHANNEL MULTIPURPOSE COIL 1.5T/3T.
North American profile: Both markets. NORAS MRI products GmbH is registered in both the United States and Canada.