The Surgical Company International B.V. (specification developer, Amsterdam Noord-Holland, NL): 1 new FDA device listing, incl. system, thermal regulating
The Surgical Company International B.V. (Amsterdam Noord-Holland): 1 new FDA device listing, incl. system, thermal regulating. Its amount of 1 is above the median of 2 (50th percentile). Dated 77 days ago, it serves as a historical benchmark. Score 60/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 1 related NL DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (2 NL records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (NL first): Titanlinks Logistics LLC (repackager or relabeler, Newark, D · Titanlinks Logistics LLC (repackager or relabeler, Newark, D · Millstone Medical Outsourcing LLC (contract manufacturer, Ol · Soher Med Limited (foreign exporter, Hong Kong, HK) · Soher Med Limited (foreign exporter, Hong Kong, HK) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: The Surgical Company International B.V. and 2 NL peers
- NL DeviceEstablishmentPulse records like this one: 2
- The Surgical Company International B.V.'s amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every NL peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for The Surgical Company International B.V. in Amsterdam Noord-Holland?
The Surgical Company International B.V. (Amsterdam Noord-Holland, NL), a specification developer (outsources manufacturing), added 1 FDA device listing on 2026-08-21.
How does The Surgical Company International B.V. compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 77 days old; check the official source for later updates before acting.
The Surgical Company International B.V. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| The Surgical Company International B.V. | Amsterdam Noord-Holland, NL | 1 | 50th | 2026-08-21 |
| Centinel Spine, LLC | West Chester, PA | 3 | 77th | 2026-10-22 |
| TORNIER Inc. | Columbia City, IN | 3 | 77th | 2026-10-21 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
Related records
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: Foreign establishment
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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.