REAL Digital International Ltd
UK-MF-000039088 · United Kingdom · Croydon
REAL Digital International Ltd is registered in the European database on medical devices as a manufacturer, with 133 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Authorised representative in the Union: Casus Europe B.V..
Devices declared under this manufacturer
- Capillary Blood Collection Kit
- Capillary Blood Collection Kit (Gold & Grey)
- HPV Collection Kit
- Sexual Health - Capillary Blood Collection Kit
- Square
- Star
- TDL Capillary Blood Collection Kit (SST & PLAIN)
- TDL Capillary Blood Collection Kit (SST)
- TDL MRSA Collection Kit
- TDL Qfit Collection Kit
- TDL Sexual Health Collection Kit
- TDL Vaginitis Collection Kit
Showing 12 of 133 declared devices.
Catalogue references include KT10001, KT10023, KT10029, KT20021, KT20040, KT20061.
European nomenclature codes declared: W05019099, W0501010299, W05019001, A99, W05010299, W0501010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | REAL DIGITAL INTERNATIONAL LIMITED (GB) · FDA 3027556151 |
| Devices in EUDAMED | 133 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 133 |
|---|---|
| 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. REAL Digital International Ltd is registered in the United States but was not found in the Canadian register.