Data / Medical devices / France / Tissium SA
Tissium SA: FDA-registered device maker in Roncq Nord, France, 1 510(k) clearance
Tissium SA is registered with the FDA (registration 3015546200) in Roncq Nord, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015546200
- Address
- TISSIUM F1 Manufacturing Site Parc Activite Pierre Mauroy, 2 rue Pierre Antoine Delahousse, Roncq Nord, France, 59223
- Owner or operator
- TISSIUM (10093777)
- Roles
- Manufacturer
- First device listed
- July 9, 2025
- Registered through
- 2026
- Brand names listed
- COAPTIUM Connect, COAPTIUM Selector, TISSIUM LIGHT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| In Situ Polymerizing Peripheral Nerve Repair Device | SFD | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | 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 |
|---|---|---|---|---|---|---|
| June 17, 2025 | DEN240066 | COAPTIUM Connect with TISSIUM LIGHT | SFD | Unknown | Tissium SA | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Non-Powered
- All makers of In Situ Polymerizing Peripheral Nerve Repair Device
Updated June 17, 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.