Data / Medical devices / Germany / Herotron E-Beam Service GmbH
Herotron E-Beam Service GmbH: FDA-registered device maker in Bitterfeld Saxony-Anhalt, Germany, 1 510(k) clearance
Herotron E-Beam Service GmbH is registered with the FDA (registration 3031571464) in Bitterfeld Saxony-Anhalt, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 10, 2004. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3031571464
- Address
- Guardianstrabe 6-10, Bitterfeld Saxony-Anhalt, Germany, 06766
- Owner or operator
- STERIS Corporation (10042227)
- Roles
- Contract sterilizer, Exporter to the US
- First device listed
- June 16, 2021
- Registered through
- 2027
- Brand names listed
- GattTech16608 (RB, BT*) - ETHIZIA Hemostatic Patch, Hollister (BT) - Vapro Plus, Hollister (BT) - Vapro Plus Pocket, Hollister (TL) - VaPro Pocket, KeySurgical6941 (DV, ED, BT(FE)) - Electro Lube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Absorbable Hemostatic, Collagen With Polymeric Additives | SGV | 3 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Straight | EZD | 2 | Contract sterilizer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | Contract sterilizer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 10, 2004 | K033880 | ELECTRO-LUBE | GEI | Substantially Equivalent | Mectra Labs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Catheter, Straight
- All makers of Shunt, Central Nervous System And Components
Updated March 10, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.