Data / Medical devices / Germany / Mie GMBH
Mie GMBH: FDA-registered device maker in SETH Schleswig-Holstein, Germany, 5 510(k) clearances
Mie GMBH is registered with the FDA (registration 3005128583) in SETH Schleswig-Holstein, Germany. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005128583
- Address
- Hauptstr. 112, SETH Schleswig-Holstein, Germany, 23845
- Owner or operator
- MIE GMBH (9028781)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- ANCORIS, ECAM SCINTRON, ECAT Scintron PET, MIE - DIACAM SCINTRON, MIE - LFOV SCINTRON, MIE - ORBITER SCINTRON, MIE - SD-X 37 SCINTRON, SCINTRON
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | 1 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 27, 2020 | K201807 | ANCORIS | KPS | Substantially Equivalent | Miegmbh | accessdata.fda.gov |
| April 19, 2013 | K130269 | ECAT SCINTRON PET | KPS | Substantially Equivalent | Miegmbh | accessdata.fda.gov |
| October 5, 2010 | K101768 | MIE SCINTRON GAMMA CAMERA SYSTEMS | KPS | Substantially Equivalent | Miegmbh | accessdata.fda.gov |
| June 7, 2010 | K101013 | MODIFICATION TO SCINTRON IV | KPS | Substantially Equivalent | Miegmbh | accessdata.fda.gov |
| January 27, 2006 | K053086 | MIE - GAMMA CAMERA SYSTEMS | KPS | Substantially Equivalent | Mie America, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 27, 2020. 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.