Data / Medical devices / Germany / Innovation Meditech GMBH
Innovation Meditech GMBH: FDA-registered device maker in UNNA North Rhine-Westphalia, Germany, 1 510(k) clearance
Innovation Meditech GMBH is registered with the FDA (registration 3004003391) in UNNA North Rhine-Westphalia, Germany. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004003391
- Address
- Max-Planck-Str. 31, UNNA North Rhine-Westphalia, Germany, 59423
- Owner or operator
- INNOVATION MEDITECH GMBH (9057092)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- June 24, 2003
- Registered through
- 2026
- Brand names listed
- Drill guide, Impression trays, Indirect Bonding Tray, Sonopal hart Lack Al, Sonopal soft Lack E
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Aligner, Bracket, Orthodontic | ECQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Earmold, Impression | LDG | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Exporter to the US | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| November 19, 2020 | K200580 | FotoDent denture | EBI | Substantially Equivalent | Dreve Dentamid GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Earmold, Impression
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Plate, Base, Shellac
- All makers of Aligner, Bracket, Orthodontic
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated November 19, 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.