Radley Scientific Ltd
GB-MF-000028143 · United Kingdom · ASHBURTON
Radley Scientific Ltd is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 7 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: Series 1.
Among these devices, 4 are declared sterile, 1 reusable, 7 active.
Authorised representative in the Union: endocon GmbH.
Devices declared under this manufacturer
- Cement 100mm Ø6mm Piercer Probe (Reusable)
- Cement 100mm Ø6mm Piercer Probe (Single-use - Sterile)
- Cement 200mm Ø4mm Piercer Probe (Reusable)
- Cement 200mm Ø4mm Piercer Probe (Single-use - Sterile)
- Cement Transducer (Reusable)
- Generator
- Short Straight Extension Bar (Reusable)
- Single Use, Axial-Grip Handpiece (Single-use – Sterile)
- TORS
Catalogue references include P4R2, P4S2, P6R1, P6S1, T1, T1AH.
European nomenclature codes declared: Z12139002, Z12139085, Z12139080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | RADLEY SCIENTIFIC LTD (GB) · FDA 3030446516 |
| Devices in EUDAMED | 9 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 100.0 % |
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. Radley Scientific Ltd is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 810665 | issued | 2031-07-02 |