Data / Medical devices / Germany / MTT GMBH
MTT GMBH: FDA-registered device maker in Lueneburg Lower Saxony, Germany, 1 510(k) clearance
MTT GMBH is registered with the FDA (registration 3011545155) in Lueneburg Lower Saxony, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011545155
- Address
- Boecklerstr. 26, Lueneburg Lower Saxony, Germany, 21339
- Owner or operator
- MTT GmbH (10048443)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- January 14, 2015
- Registered through
- 2026
- Brand names listed
- BioJet, PeriGrid Disposable, PeriGrid HDR, PeriGrid Reusable, Probe receptacle (SB) SIUI ECBP (ACCESSORY to Stepper), Single Use Disposable Template, SolidLock F, SolidLock F-500ext and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastroenterology-Urology Accessories To A Biopsy Instrument | QFZ | 1 | Manufacturer | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 16, 2012 | K122329 | BIOJET | LLZ | Substantially Equivalent | Jet Soft Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
- All makers of System, Applicator, Radionuclide, Manual
- All makers of Gastroenterology-Urology Accessories To A Biopsy Instrument
- All makers of System, Image Processing, Radiological
Updated August 16, 2012. 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.