Data / Medical devices / Germany / MedFact Engineering GmbH
MedFact Engineering GmbH: FDA-registered device maker in Loerrach Baden-Wurttemberg, Germany, 1 510(k) clearance
MedFact Engineering GmbH is registered with the FDA (registration 3008497357) in Loerrach Baden-Wurttemberg, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008497357
- Address
- Hammerstr. 3, Loerrach Baden-Wurttemberg, Germany, 79540
- Owner or operator
- MEDFACT ENGINEERING GMBH (10045544)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- December 6, 2016
- Registered through
- 2026
- Brand names listed
- 4F PV Catheters, 7F PV Catheters, EProC Esophageal Retractor, EasyMap MAP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, 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 18, 2016 | K151139 | EasyMap MAP Catheter | DRF | Substantially Equivalent | Medfact Engineering GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Retractor
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
Updated October 18, 2016. 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.