Data / Medical devices / Netherlands / The Surgical Company International B.V.
The Surgical Company International B.V.: FDA-registered device maker in Amsterdam Noord-Holland, Netherlands, 5 510(k) clearances
The Surgical Company International B.V. is registered with the FDA (registration 3038241934) in Amsterdam Noord-Holland, Netherlands. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 7, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038241934
- Address
- Paalbergweg 3, Amsterdam Noord-Holland, Netherlands, 1105 AG
- Owner or operator
- THE SURGICAL COMPANY INTERNATIONAL BV (9101201)
- Roles
- Specification developer
- First device listed
- July 8, 2010
- Registered through
- 2026
- Brand names listed
- Fluido Compact Control Module, Fluido Compact Standard Set, Fluido Compact Standard Set with Drip Chamber, Fluido Compact Warming Module, Fluido® AirGuard, Fluido® Blood & Fluid Warmer (115V), Fluido® Compact Holder, Fluido® Compressor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stand, Infusion | FOX | 1 | Specification developer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Specification developer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 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 |
|---|---|---|---|---|---|---|
| August 7, 2026 | K261437 | Mistral-Air® Warming System | DWJ | Substantially Equivalent | The Surgical Company International B.V., doing business as TSC Life | accessdata.fda.gov |
| November 18, 2025 | K252636 | Fluido Compact System | LGZ | Substantially Equivalent | The Surgical Company International B.V. | accessdata.fda.gov |
| September 4, 2025 | K251733 | Fluido® AirGuard System | LGZ | Substantially Equivalent | The Surgical Company International BV (As Tsc Life) | accessdata.fda.gov |
| May 26, 2017 | K171234 | Mistral-Air Warming Unit | DWJ | Substantially Equivalent | The Surgical Company International BV (As the 37company) | accessdata.fda.gov |
| July 2, 2010 | K101705 | MISTRAL-AIR WARMING SYSTEM | DWJ | Substantially Equivalent | The Surgical Company International B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Thermal Regulating
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Stand, Infusion
Updated August 7, 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.