Remel Europe Ltd
GB-MF-000016733 · United Kingdom · Dartford, Kent
Remel Europe Ltd is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Authorised representative in the Union: Thermo Fisher Diagnostics B.V..
Devices declared under this manufacturer
- PATHODX EXTRACTION REAGENT 1
- PATHODX EXTRACTION REAGENT 2
- PATHODX HERPES TYPING CONTROL SLIDES
- PATHODX STREP G GROUPING LATEX
- PATHODX STREP GROUPING KIT
- PATHODX STREP GROUPING UNIVERSAL KIT
- STREPTEX
- STREPTEX ACID EXTRACTION KIT
- STREPTEX DISPOSABLE REACTION CARDS
- STREPTEX LATEX A
- STREPTEX LATEX G
- Staphaurex Disposable Reaction Cards (50 cards per pack)
Showing 12 of 39 declared devices.
Catalogue references include R30368601, R30369001, R30858301, R30859902, R30950501, R30951301.
European nomenclature codes declared: W0105011101, W0105011199, W0104080303, W0104080301, W0105080804, W0104080399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | REMEL EUROPE LTD (GB) · FDA 3003750284 |
| Devices in EUDAMED | 39 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 39 |
|---|---|
| Found in the U.S. device database | 37 |
| Share | 94.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | REMEL EUROPE LIMITED |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 5 |
| First licensed | 1998-12-23 |
Licence types: Test Kit (5).
Licensed under: PATHODX HERPES TYPING, PATHODX CHLAMYDIA CULTURE CONFIRMATION KIT, PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN, WELLCOGEN BACTERIAL ANTIGEN DETECTION KIT, WELLCOGEN STREP B.
North American profile: Both markets. Remel Europe Ltd is registered in both the United States and Canada.