RAPID Biomedical GmbH
DE-MF-000008285 · Germany · Rimpar
RAPID Biomedical GmbH is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 78 |
|---|
Among these devices, 72 are declared active.
Devices declared under this manufacturer
- 129Xe Torso Coil
- 13C Torso Coil
- 13C/1H Head Coil
- 13C/1H Surface Coil
- 19F/1H Surface Coil Flex
- 1H Breast Array
- 1H Head Coil
- 2H/1H Head Coil
- 31P/1H Head Coil
- 31P/1H Surface Coil Flex
- 31P/1H Surface Coil flex
- Dental Nose Cushion Set
Showing 12 of 78 declared devices.
Catalogue references include 01688, 02005, 02113, 02116, 02153, 02226.
European nomenclature codes declared: Z11059080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | RAPID BIOMEDICAL GMBH (DE) · FDA 3005049692 |
| Devices in EUDAMED | 78 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 78 |
|---|---|
| Found in the U.S. device database | 20 |
| Share | 25.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | RAPID BIOMEDICAL GMBH |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 2018-12-18 |
Licence types: Device Family (4), Single Device (3).
Licensed under: 16CH DIAGNOSTIC BREAST COIL, ENDORECTAL COIL, HEAD COIL (7T) FOR MAGNETOM TERRA, FLEX LOOP COIL (7T) FOR MAGNETOM TERRA, 140-FLEX COIL, HEAD COILS.
North American profile: Both markets. RAPID Biomedical GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1419035-1 | issued | 2026-02-11 |
HZ 1419035-1 | reissued | 2031-02-11 |