Data / Medical devices / Germany / Corscience GMBH & Co. KG
Corscience GMBH & Co. KG: FDA-registered device maker in ERLANGEN Bavaria, Germany, 1 510(k) clearance
Corscience GMBH & Co. KG is registered with the FDA (registration 3005488716) in ERLANGEN Bavaria, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 28, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005488716
- Address
- Hartmannstr. 65, ERLANGEN Bavaria, Germany, 91052
- Owner or operator
- Corscience GmbH & Co. KG (10047753)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 7, 2019
- Registered through
- 2027
- Brand names listed
- COR12, GoECG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 28, 2018 | K183369 | COR12 ECG | DPS | Substantially Equivalent | Corscience GmbH & Co. | accessdata.fda.gov |
Compare with other makers
Updated December 28, 2018. 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.