BGI EUROPE A/S
DK-MF-000014089 · Denmark · Herlev
BGI EUROPE A/S is registered in the European database on medical devices as a manufacturer, with 140 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 1 test/kit, 5 tests/kit, 50 tests/kit, 50 tests/kit, 1000 tests/kit, 50 tests/kit, 200 tests/kit.
Devices declared under this manufacturer
- BGI
- NIFTY®
- Nucleic Acid Extraction Kit
Showing 12 of 140 declared devices.
Catalogue references include EU0200050006 (PBC20A Plus), MFG010039, MFG020002, MFG030034, MFG030035, MFG030110, MFG030111, MFG030112, MFG030112.
European nomenclature codes declared: W010699, W0106010306, W0201010102, W0105090401, W0101060107, W0105010402.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 140 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 70 |
|---|---|
| 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: Neither register. BGI EUROPE A/S was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V13 125836 0004 | issued | 2031-06-28 |