RSR Limited
GB-MF-000025180 · United Kingdom · Cardiff
RSR Limited is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: ElisaRSR™ 21-OH Ab with Calibrators, ElisaRSR™ 21-OH Ab with Reference Prep Only, ElisaRSR™ 3 Screen ICA™ with Calibrators, ElisaRSR™ 3 Screen ICA™ with Reference Prep Only, RiaRSR™ AChRAb 100 Tube.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- ElisaRSR™ 2 Screen ICA™
- ElisaRSR™ 21-OH Ab
- ElisaRSR™ 3 Screen ICA™
- ElisaRSR™ AChRAb
- ElisaRSR™ Fast 2 Screen ICA™
- ElisaRSR™ Fast AChRAb
- ElisaRSR™ Fast ZnT8 Ab™
- ElisaRSR™ IA-2 Ab
- ElisaRSR™ IA-2 Ab Version 2
- ElisaRSR™ ZnT8 Ab™
- ElisaRSR™TRAb 2nd Generation
- RiaRSR™ AChRAb
Showing 12 of 30 declared devices.
Catalogue references include 21E/96, 2GI/96, 3ZGI/96, ACE/96, FAE/96, FGIE/96.
European nomenclature codes declared: W0102109022, W0102100302, W0102060105, W0102109099, W0102100299, W0102060106.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | RSR LTD. (GB) · FDA 3003834021 |
| Devices in EUDAMED | 30 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. RSR Limited is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IVDR 814965 | issued | 2031-07-02 |