SERO AS
NO-MF-000012954 · Norway · Billingstad
SERO AS is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Autonorm® Immunoassay Liq L-1
- Autonorm® Immunoassay Liq L-3
- Autonorm® Immunoassay Lyo L-1
- Autonorm® Immunoassay Lyo L-3
- Autonorm® Pharmaca Liq L-2
- SERO Lumipulse IA Control L-1 / L-2
- SERO Maternal Health® Control - Early
- Seronorm® CRP Liquid L-2
- Seronorm® CRP Liquid L-3
- Seronorm® Cardiac Acute Lyo L-1B
- Seronorm® Cardiac Acute Lyo L-3
- Seronorm® HbA1c Liquid L-1
Showing 12 of 52 declared devices.
Catalogue references include 204805, 206805, 209105, 210605, 211805, 212105.
European nomenclature codes declared: W01021521, W0101050101, W0102152004, W0101050299, W0102152003, W0101050205.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SERO AS (NO) · FDA 3001431095 |
| Devices in EUDAMED | 52 |
| Country of registration | Norway |
Device-level evidence
| Devices with a numeric GTIN | 52 |
|---|---|
| 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: United States only. SERO AS is registered in the United States but was not found in the Canadian register.