Edif Instruments S.r.l.
IT-MF-000009556 · Italy · Rome
Edif Instruments S.r.l. is registered in the European database on medical devices as a manufacturer, with 139 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Closing lid for individual reagent position, Kit Accessories, NeaT S System solution, PMMA reaction washable cuvettes starter kit (20 pcs) + extraction tool, Pulsar - Automated Immunochemistry Analyser.
Devices declared under this manufacturer
- Closing lid for individual reagent position
- Kit Accessories
- Kit Accessories QCA Bio 100
- NeaT C Cleaning solution 2 x 250 mL
- Pack of reagent Bottle 50ml for 30 positions tray (30 pcs)
- Pack of specimen collection cups 1mL (50pcs)
- Pack of specimen collection cups, 3mL (50 pcs)
- Pulsar
- Reaction Cells starter kit (20 Pcs) V shape + extraction tool ACC07017
- Removable sample tray 20+20 positions with tubes clips, 12/16mm tubes
- Sample tray for ES00004 (1 - 10) up to 13mm vacuum tubes
- Specimen collection screw cap tube 10.8 x 44 mm (2 mL)
Showing 12 of 139 declared devices.
Catalogue references include ACC07036A-001A, ACC07047A-001A, ACC07100, ACC07201G-001A, CML07022A-050A, CML07023A-050A.
European nomenclature codes declared: W0201010185,W0201020185, W0201010180,W0201020180, W0201010101,W0201020102, W0201010192,W0201020192, W0201010101,W0201020103, W0201010182,W0201020185.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 139 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 139 |
|---|---|
| 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. Edif Instruments S.r.l. was not found in either the U.S. or the Canadian register.