Data / Medical devices / Canada / CSD Labs International Inc.
CSD Labs International Inc.: FDA-registered device maker in Ottawa Ontario, Canada, 1 510(k) clearance
CSD Labs International Inc. is registered with the FDA (registration 3016442138) in Ottawa Ontario, Canada. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016442138
- Address
- 78 George St Suite 204, Ottawa Ontario, Canada, K1N 5W1
- Owner or operator
- CSD Labs GmbH (10062365)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 23, 2025
- Registered through
- 2026
- Brand names listed
- eMurmur Heart AI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Phonocardiograph | DQC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| December 19, 2025 | K252284 | eMurmur Heart AI | DQD | Substantially Equivalent | Csd Labs | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2025. 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.