Remote Diagnostic Technologies Ltd.
GB-MF-000002127 · United Kingdom · Farnborough
Remote Diagnostic Technologies Ltd. is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 21 |
|---|---|
| Class IIb | 8 |
Most frequent device types declared: 00-1004-R / 867420, 00-1007-R / 867421, 00-1024-R / 867422, 00-1026-R / 867423, 00-2001-R.
Among these devices, 28 are declared active, 7 with a measuring function.
Authorised representative in the Union: Philips Medical Systems Nederland B.V..
Devices declared under this manufacturer
- 2-Channel Invasive Pressure Module
- 3-Lead ECG Cable (IEC) 8ft
- 3-Lead Neo ECG Modular Cable (IEC) 6ft
- 4-Lead ECG Modular Cable (IEC) 8ft
- 5-Lead ECG Cable (IEC) 6ft
- ECG Harness
- IntelliSpace Corsium
- Invasive Pressure Adaptor 2 Channel- Edwards TruWave 8ft
- Tempus IC2
- Tempus Pro 2-Channel Invasive Pressure Universal Cable
- Tempus Pro Patient Monitor
- Tempus Pro Printer Paper with 110mm Grid
Showing 12 of 29 declared devices.
Catalogue references include 00-2001-R, 01-2039 / 989706010290, 01-2052 / 989706010060, 01-2071 / 989706000551, 01-2113 / 989706000691, 01-2202 / 989706000981.
European nomenclature codes declared: Z12050380, Z1203020299, Z1203020301, Z1203020202, Z1203020282, Z12050385.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. (GB) · FDA 3003832357 |
| Devices in EUDAMED | 29 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 29 |
|---|---|
| Found in the U.S. device database | 20 |
| Share | 69.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2013-12-23 |
Licence types: Single Device (1).
Licensed under: TEMPUS PRO.
North American profile: Both markets. Remote Diagnostic Technologies Ltd. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620139844-01 | issued | 2027-07-04 |