Establishment registration
TOMTEC Imaging Systems GMBH
FDA establishment registration 8043836 · UNTERSCHLEISSHEIM Bavaria, DE
Key facts
| Registration number | 8043836 |
|---|---|
| Establishment name | TOMTEC Imaging Systems GMBH |
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| FEI number | 1000185293 |
| Address | Freisinger Strasse 9 |
| City | UNTERSCHLEISSHEIM Bavaria |
| Country | DE |
| Registration valid through | 2026 |
| Product codes listed | IYN, LLZ, QIH |
| Device classes | 2 |
At a glance
- 1–9 Device listings
- 10–99 UDI devices (GUDID)
- Current Registration current
- 1–9 FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database