Establishment registration
Helena Laboratories UK Ltd
FDA establishment registration 3009736003 · Gateshead Newcastle upon Tyne, GB
Key facts
| Registration number | 3009736003 |
|---|---|
| Establishment name | Helena Laboratories UK Ltd |
| Owner/operator | Helena Biosciences Europe |
| Owner/operator number | 10041365 |
| FEI number | 3009736003 |
| Address | Queensway South |
| City | Gateshead Newcastle upon Tyne |
| Country | GB |
| Registration valid through | 2026 |
| Product codes listed | CEF, CFF |
| Device classes | 1, 2 |
At a glance
- 1–9 Device listings
- 1–9 UDI devices (GUDID)
- Current Registration current
- 1–9 FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database