Leica Biosystems Newcastle Ltd
GB-MF-000020595 · United Kingdom · Newcastle Upon Tyne
Leica Biosystems Newcastle Ltd is registered in the European database on medical devices as a manufacturer, with 306 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: KBI-XL006, KBI-XL015, NCL-L-E-Cad, NCL-L-END, NCL-L-LL002.
Authorised representative in the Union: AR Experts B.V..
Devices declared under this manufacturer
- CD15 MMA 7 mL
- DDIT3 (12q13) Proximal - XL
- Leica HER2 FISH System - 30 Test
- MYC (8q24) Distal - XL
- NCL-L-CD2-271
- NCL-L-E-Cad
- NCL-L-END
- NCL-L-LL002
- NCL-L-MSH6
- NCL-L-S100-167
- NCL-L-b-SARC
- Novolink Polymer Detection System (500 tests)
Showing 12 of 306 declared devices.
Catalogue references include KBI-XL006, KBI-XL015, NCL-L-E-Cad, NCL-L-END, NCL-L-LL002, NCL-L-MSH6.
European nomenclature codes declared: W01030709, W01060299, W0103010199, W01030799, W01030703, W01030711.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LEICA BIOSYSTEMS NEWCASTLE LTD (GB) · FDA 3004859032 |
| Devices in EUDAMED | 306 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 306 |
|---|---|
| Found in the U.S. device database | 264 |
| Share | 86.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LEICA BIOSYSTEMS NEWCASTLE LTD. |
What it holds in Canada
| Licences on record | 295 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 294 |
| Class 3 devices | 1 |
| First licensed | 2005-03-30 |
Licence types: Single Device (167), Device Family (116), Test Kit (8), System (2).
Licensed under: NOVOCASTRA LIQUID MOUSE MONOCLONAL ANTIBODY CD, MOUSE MONOCLONAL CD10-270, MOUSE MONOCLONALS DYS1/2/3, MOUSE MONOCLONAL CD5-4C7, MOUSE MONOCLONAL KI67-MM1, NOVOCASTRA LIQUID MOUSE MONOCLONAL ANTIBODY EN.
North American profile: Both markets. Leica Biosystems Newcastle Ltd is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IVDR 739320 | reissued | 2031-06-07 |