Data / Medical devices / Germany / Cnsac Medshop GMBH
Cnsac Medshop GMBH: FDA-registered device maker in Theilheim Bavaria, Germany, 2 510(k) clearances
Cnsac Medshop GMBH is registered with the FDA (registration 3014236293) in Theilheim Bavaria, Germany. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 24, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3014236293
- Address
- Biebelrieder Str 42, Theilheim Bavaria, Germany, 97288
- Owner or operator
- CNSAC MedShop GmbH (10088631)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 8, 2023
- Registered through
- 2027
- Brand names listed
- CNSAC Adhesive rings (double-sided), CNSAC CPAP adapter including 80 cm (31'') PVC tube, 100 pcs., with (male) Luer-Lock connector, CNSAC Nasal Cannula for Newborn (up to 10 months), with (male) Luer-Lock connector, CNSAC Nasal Cannula for Pediatric (from 1 year on), with (male) Luer-Lock connector, CNSAC Nasal Cannula including filter connector compatible with NOX, 60 cm (24) tubing, CNSAC Nasal Cannula, adults, 150 cm (60?) tubing with (male) Luer-Lock connector, CNSAC Nasal Cannula, adults, 210 cm (83?) tubing with (female) Luer-Lock connector, CNSAC Nasal Cannula, adults, 210 cm (83?) tubing with (male) Luer-Lock connector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Specification developer | accessdata.fda.gov |
| Unit, Filter, Membrane | JRL | 1 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | 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 |
|---|---|---|---|---|---|---|
| September 24, 2026 | K260949 | Disposable Belts for Polysomnography (CNSAC) | MNR | Substantially Equivalent | CNSAC Medshop GmbH | accessdata.fda.gov |
| June 15, 2022 | K212325 | EEG-acp | GYB | Substantially Equivalent | Somnomedics GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Electroconductive
- All makers of Ventilatory Effort Recorder
- All makers of Tape And Bandage, Adhesive
- All makers of Cannula, Nasal, Oxygen
- All makers of Mouthpiece, Breathing
- All makers of Electrode, Electrocardiograph
Updated September 24, 2026. 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.