Shandon Diagnostics Limited
GB-MF-000008187 · United Kingdom · Cheshire
Shandon Diagnostics Limited is registered in the European database on medical devices as a manufacturer, with 392 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Authorised representative in the Union: Epredia Netherlands B.V..
Devices declared under this manufacturer
- BASKET AND CARRIER
- Cool-Cut
- Cryostar NX50 HOVP HC
- Cryostar NX50 OVP HC
- Cryostar NX50 HOP
- Cryostar NX50 HOVPD
- Cytospin 4
- Gemini AS
- Laser Biopsy Cassettes - Pink
- Laser Embedding Cassettes - Aqua
- Laser Embedding Cassettes - Beige
- Laser Embedding Cassettes - Green
Showing 12 of 392 declared devices.
Catalogue references include 771110, 957130, 957170, 957180L, 957200, A78010466.
European nomenclature codes declared: W05020106, W0202059003, W0202059002, W0202059010, W0202059005, W0202059008.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SHANDON DIAGNOSTICS LIMITED (GB) · FDA 3003584784 |
| Devices in EUDAMED | 392 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 392 |
|---|---|
| Found in the U.S. device database | 204 |
| Share | 52.0 % |
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. Shandon Diagnostics Limited is registered in the United States but was not found in the Canadian register.