Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038241934

FEI Number

3038241934

Entity Name

The Surgical Company International B.V.

City/State/Country

Amsterdam Noord-Holland, NL

Establishment Address

Paalbergweg 3, Amsterdam Noord-Holland 1105 AG, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

THE SURGICAL COMPANY INTERNATIONAL BV (Owner Number: 9101201)

Owner / Operator Contact Address

Paalbergweg 3, --, Amsterdam, NL-NH 1105 AG, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251733

PMA Number

N/A

All Registered Proprietary Names

Fluido Compact Control Module Fluido Compact Warming Module Fluido Compact Standard Set Fluido Compact Standard Set with Drip Chamber Mistral-Air Half Upper Body Blanket (silver) Mistral-Air Tube (blue) Mistral-Air Full Underbody (silver) Mistral-Air Full Body Surgical Access - Sterile (white) Mistral-Air Upper Body Blanket (white) Mistral-Air Paediatric Blanket (white) Mistral-Air Paediatric Blanket (silver) Mistral-Air Torso Blanket (white) Mistral-Air Adult Blanket (silver) Mistral-Air Adult Blanket (white) Mistral-Air Lower Body Blanket (white) Mistral-Air Plus Warming Unit 110-120V~, 60Hz Mistral-Air Lower Body Blanket (silver) Mistral-Air Full Body Surgical Access - Non-sterile (white) Mistral-Air Upper Body Blanket (silver) Mistral-Air Underbody (silver) Mistral-Air Neonatal Blanket (silver) Mistral-Air Half Upper Body Blanket (white) 672100 Fluido Compact Standard Set with Drip Chamber 650200 Fluido Compact Warming Module 650100-US Fluido Compact Control Module 672000 Fluido Compact Standard Set Fluido® Blood & Fluid Warmer (115V) Fluido® Compressor Fluido® Standard Set Fluido® IV-Pole Fluido® Pressure Chambers Fluido® Trauma Set Fluido® AirGuard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2025-12-03
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2010-07-08
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2023-06-06
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2025-09-08

Official Correspondent

Federica Federici

US Agent Details

Christopher Duffie Business: TSC Life US, Inc. Email: fda.tsclife-us@tsc-life.com Phone: (773) 5204980

Related Public Records

Same Entity

THE SURGICAL COMPANY INTERNATIONAL BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021073836	TSC Life	Almelo Overijssel, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3003018304	ECM EUROPE BV	Gemert Noord-Brabant, NL
3006715577	A/S KURT HANSEN	Svendborg Syddanmark, DK
9614609	PROVITA Medical GmbH & Co. KG	WERMELSKIRCHEN North Rhine-Westphalia, DE
3010317211	TRIBALCO	Tampa, FL, US
3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038241934. Last updated year: 2026. Please use registration number 3038241934 when referencing this establishment in official correspondence.