# The Surgical Company International B.V. (specification developer, Amsterdam Noord-Holland, NL): 1 new FDA device listing, incl. system, thermal regulating

**Score:** 60/100

| Field | Value |
|---|---|
| Establishment | The Surgical Company International B.V. |
| Owner / operator | The Surgical Company International BV |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Amsterdam Noord-Holland, NL |
| New listings | 1 |
| Devices | System, Thermal Regulating |
| Product codes | DWJ |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | Mistral Air® Upper Body Plus; Mistral Air® Cardiac Blanket (sterile); Mistral Air® Premium Half Upper Body; Mistral Air® Warming Blanket Tube; Mistral Air® Lower Body Plus; Mistral Air® Surgical Access Plus (sterile); Mistral Air® Premium Warming Suit M; Mistral Air® Premium Warming Suit L |
| First new listing | 2026-08-21 |
| Latest new listing | 2026-08-21 |
| FDA registration number | 3038241934 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.