Newmarket Biomedical Ltd
GB-MF-000025155 · United Kingdom · Kentford, Suffolk
Newmarket Biomedical Ltd is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: NewBio Syphilis EIA TA, PK7400 TP HA Controls, PK7400 TP HA Reagent, RPR, TPHA.
Authorised representative in the Union: MDSS GmbH.
Devices declared under this manufacturer
- NewBio Syphilis EIA TA - 96 Test Kit
- Newbio RPR 100
- Newbio RPR 500
- Newbio TPHA 100
- Newbio TPHA 1000
- Newbio TPHA 200
- PK7400 TP HA Controls
- PK7400 TP HA Reagent
Showing 12 of 13 declared devices.
Catalogue references include B11186, B11187, NB007, NB008, NB009, NB010.
European nomenclature codes declared: W0105010302, W0105010399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NEWMARKET BIOMEDICAL LTD (GB) · FDA 3011801330 |
| Devices in EUDAMED | 13 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 15.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NEWMARKET BIOMEDICAL LTD |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 4 devices | 1 |
| First licensed | 2020-02-24 |
Licence types: Test Kit (1).
Licensed under: PK7400 TP HA REAGENT AND CONTROLS (DONOR SCREE.
North American profile: Both markets. Newmarket Biomedical Ltd is registered in both the United States and Canada.