Data / Medical devices / Denmark / Cimpax A/S
Cimpax A/S: FDA-registered device maker in Slangerup Hovedstaden, Denmark, 2 510(k) clearances
Cimpax A/S is registered with the FDA (registration 3015460875) in Slangerup Hovedstaden, Denmark. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 16, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015460875
- Address
- Lille Pilevang 4, Slangerup Hovedstaden, Denmark, 3550
- Owner or operator
- CIMPAX A/S (10061849)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- November 25, 2019
- Registered through
- 2026
- Brand names listed
- C-CAT Anesthesia Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Conduction, Anesthetic | BSO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 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 |
|---|---|---|---|---|---|---|
| October 16, 2020 | K201129 | Medline Smoke Evacuation Pencil | GEI | Substantially Equivalent | Medline Industires, Inc. | accessdata.fda.gov |
| October 25, 2019 | K191470 | C-CAT Anaesthesia Catheter kit | BSO | Substantially Equivalent | Cimpax Aps | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Catheter, Conduction, Anesthetic
Updated October 16, 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.