Data / Medical devices / Germany / MT.DERM GmbH
MT.DERM GmbH: FDA-registered device maker in Berlin, Germany, 3 510(k) clearances
MT.DERM GmbH is registered with the FDA (registration 3006634874) in Berlin, Germany. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006634874
- Address
- Blohmstrasse 37-61, Berlin, Germany, 12307
- Owner or operator
- MT.DERM GmbH (10058532)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 8, 2018
- Registered through
- 2026
- Brand names listed
- 6-MNP 1.5 Exceed II 2, 6-MNP 1.5 Exceed II 3, 6-MNP 1.5 Exceed US, 6-MNP 1.5 ToskaniMED US, Bio Touch Aero, Bio Touch Precision, Exceed Unlimited, Footswitch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Microneedle Device | QAI | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 23, 2024 | K233709 | Exceed Unlimited | QAI | Substantially Equivalent | Mt. Derm GmbH | accessdata.fda.gov |
| July 19, 2019 | K182407 | Exceed Microneedling device | QAI | Substantially Equivalent | Mt. Derm GmbH | accessdata.fda.gov |
| September 7, 2018 | K180778 | Exceed Microneedling Device | QAI | Substantially Equivalent | Mt. Derm GmbH | accessdata.fda.gov |
Compare with other makers
Updated February 23, 2024. 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.