IST Innuscreen GmbH
DE-MF-000024606 · Germany · Berlin
IST Innuscreen GmbH is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- -\tdeltaPREP Blood DNA Kit – PP Mini (MDX) Strip 16 rxn
- PurePrep Path DX Kit (96 rxn)
- deltaPREP Blood DNA Kit – PP Mini (MDX)
- deltaPREP Blood DNA Mini Kit – IPC16 (MDX)
- deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (16 rxn) Plates
- deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (480 rxn) Plates
- deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (96 rxn) plates
- deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (96 rxn) stripes
- deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn)
- deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn) Plates
- deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (480 rxn) Plates
- deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (96 rxn) Plates
Showing 12 of 18 declared devices.
Catalogue references include 31-DP-2000096, 31-DP-4000016, 31-DP-4010096, 31-DP-5000096, 31-DP-5010096, 31-DP-6000016.
European nomenclature codes declared: W01019001.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 18 |
|---|---|
| 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. IST Innuscreen GmbH was not found in either the U.S. or the Canadian register.