Wallac Oy
FI-MF-000022620 · Finland · Turku
Wallac Oy is registered in the European database on medical devices as a manufacturer, with 170 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- BoBsoft
- DELFIA Enhancement Solution
- DELFIA Inducer
- DELFIA Wash Concentrate
- DELFIA Xpress PlGF
- DELFIA Xpress PlGF 1-2-3
- DELFIA/AutoDELFIA PlGF kit
- LifeCycle for Prenatal Screening
- NeoBase Non-derivatized Assay Solutions
- Neonatal Biotinidase kit
- Panthera-Puncher 9
- RESOLVE Hemoglobin Kit
Showing 12 of 170 declared devices.
Catalogue references include 2029-0010, 2081-0010, 3018-0010, 3041-0020, 3097-0020, 6007-0050.
European nomenclature codes declared: W0102050299, W01029003, W01019001, W01019099, W01010199, W0106010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | WALLAC OY (FI) · FDA 8043909 |
| Devices in EUDAMED | 170 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 170 |
|---|---|
| Found in the U.S. device database | 53 |
| Share | 31.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | WALLAC OY |
What it holds in Canada
| Licences on record | 23 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| Class 3 devices | 18 |
| First licensed | 1999-11-01 |
Licence types: Test Kit (10), System (9), Device Family (3), Single Device (1).
Licensed under: DELFIA XPRESS 6000 IMMUNOANALYZER SYSTEM, NEONATAL GALT KIT, LIFECYCLE FOR PRENATAL SCREENING, NEOBASE NON-DERIVATIZED MSMS KIT, NEONATAL BIOTINIDASE KIT, PIGF CONTROLS.
North American profile: Both markets. Wallac Oy is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-04-1088-893-25 | supplemented | 2029-06-26 |