Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021073836

FEI Number

3021073836

Entity Name

TSC Life

City/State/Country

Almelo Overijssel, NL

Establishment Address

Bedrijvenpark Twente Noord 48, --, Almelo Overijssel 7602 KR, NL

Establishment Type(s)

Manufacture Medical Device

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Fluido® Blood & Fluid Warmer (115V) Fluido® Compressor Fluido® Standard Set Fluido® IV-Pole Fluido® Pressure Chambers Fluido® Trauma Set Fluido® AirGuard Fluido Compact Control Module Fluido Compact Warming Module Fluido Compact Standard Set Fluido Compact Standard Set with Drip Chamber 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® Compact Holder

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	2025-09-08
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2025-12-03
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2023-06-06
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-05-27

Official Correspondent

Federica Federici

US Agent Details

Chris Duffie Business: TSC Life US Inc. Email: fda.tsclife-us@tsc-group.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
3038241934	The Surgical Company International B.V.	Amsterdam Noord-Holland, NL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021073836. Last updated year: 2026. Please use registration number 3021073836 when referencing this establishment in official correspondence.