Establishment registration
BIOTRONIK SE & CO. KG
FDA establishment registration 9610139 · BERLIN, DE
Key facts
| Registration number | 9610139 |
|---|---|
| Establishment name | BIOTRONIK SE & CO. KG |
| Owner/operator | BIOTRONIK SE & CO. KG |
| Owner/operator number | 9018331 |
| FEI number | 3002806500 |
| Address | WOERMANNKEHRE 1 |
| City | BERLIN |
| Country | DE |
| Establishment types | Specification developer, Repackager/relabeler, Complaint file establishment, Foreign exporter |
| Registration valid through | 2026 |
| Product codes listed | DQX, DQY, DRB, DRE, DRF, DTA, DTB, DTC, DTD, DTE, DTG, DXY, KRG, LGW, LWP, LWS, MRM, MXD, NIK, NKE, NVN, NVY, NVZ, OJX, OSR, OVJ |
| Device classes | 1, 2, 3 |
At a glance
- 10–99 Device listings
- 1,000+ UDI devices (GUDID)
- Current Registration current
- 10–99 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