Biochrom Ltd
GB-MF-000025158 · United Kingdom · Cambridge
Biochrom Ltd is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: Bio30+.
Authorised representative in the Union: MDSS GmbH.
Devices declared under this manufacturer
- Bio 30+ Physio Accelerated
- Bio 30+ Physio W/O A/S HP
- Bio 30+ Physio W/O A/S HR
- Bio 30+ Physiological HR
- Bio 30+ Sys Physio HP EZ Nin
- Bio 30+ System Physio HP
- Bio 30+ System Physio HR
- Bio30+ Physio Accel W/O A/S
- Bio30+ System Physio Accel
Catalogue references include 80-6000-50, 80-6000-51, 80-6000-52, 80-6000-53, 80-6000-53EZ, 80-6000-55.
European nomenclature codes declared: W02010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIOCHROM LTD (GB) · FDA 3003521949 |
| Devices in EUDAMED | 9 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOCHROM LTD |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2016-07-29 |
Licence types: System (1).
Licensed under: ULTRA PHYSIOLOGICAL FLUID SYSTEM (AMINO ACID D.
North American profile: Both markets. Biochrom Ltd is registered in both the United States and Canada.