Data / Medical devices / Germany / Tunap GMBH & Co. KG
Tunap GMBH & Co. KG: FDA-registered device maker in Wolfratshausen Bavaria, Germany, 1 510(k) clearance
Tunap GMBH & Co. KG is registered with the FDA (registration 3014471275) in Wolfratshausen Bavaria, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 19, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014471275
- Address
- Buergermeister-Seidl-Strasse 2, Wolfratshausen Bavaria, Germany, 82515
- Owner or operator
- TUNAP GmbH & Co. KG (10057729)
- Roles
- Manufacturer
- First device listed
- March 22, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | 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 |
|---|---|---|---|---|---|---|
| October 19, 2006 | K062418 | K-SPRAY, MODEL 085-2715 | EFB | Substantially Equivalent | Scican | accessdata.fda.gov |
Compare with other makers
Updated October 19, 2006. 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.