Instrumentation Laboratory SpA
IT-MF-000009277 · Italy · Milan
Instrumentation Laboratory SpA is registered in the European database on medical devices as a manufacturer, with 112 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 0001156007, 0001156017, 0001156028, 0018162512, 0018164340.
Devices declared under this manufacturer
- Amylase
- CK
- Calcium Arsenazo
- DRI Benzodiazepine
- External Barcode Reader
- Glycated Albumin
- ILab Taurus Halogen Lamp
- ILab Taurus Rack Holder (small)
- ILab Taurus Racks Labels
- ILab Taurus Touch Screen Option Kit 2022
- ISE Cleaning
- SeraChem Control Level 2
Showing 12 of 112 declared devices.
Catalogue references include 0001156007, 0001156028, 0018164640, 0018166400, 0018471350, 0018482900.
European nomenclature codes declared: W0201010180, W0201010185, W01019001, W0102152209, W0101070302, W0101050101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INSTRUMENTATION LABORATORY SPA (IT) · FDA 3012348571 |
| Devices in EUDAMED | 112 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 112 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | INSTRUMENTATION LABORATORY CO. |
What it holds in Canada
| Licences on record | 96 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 69 |
| Class 3 devices | 27 |
| First licensed | 1999-06-29 |
Licence types: Test Kit (52), Single Device (18), Device Family (17), System (7).
Licensed under: HEMOSIL Q.F.A. THROMBIN (BOVINE), COATEST HEPARIN, COATEST APC RESISTANCE - C AND COATEST APC RES, COATEST APC RESISTANCE - V AND COATEST APC RES, COAMATIC HEPARIN, COAMATIC FACTOR VIII.
North American profile: Both markets. Instrumentation Laboratory SpA is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V12 034483 0002 | supplemented | 2026-11-02 |