Data / Medical devices / Germany / Ermis MedTech
Ermis MedTech: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 1 510(k) clearance
Ermis MedTech is registered with the FDA (registration 3005071827) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 5, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005071827
- Address
- Dornierstrasse 49, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
- Owner or operator
- Ermis MedTech GmbH (9071497)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 18, 2005
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Tonsil Suction | KCB | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical
- All makers of Container, Specimen, Non-Sterile
- All makers of Scissors, General, Surgical
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Clamp, Surgical, General & Plastic Surgery
- All makers of Holder, Needle, Gastroenterologic
Updated July 5, 2013. 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.