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The Surgical Company International B.V.

Netherlands·NL-MF-000001973

Last updated September 17, 2026

About

TSC Life is the result of the merger of The Surgical Company's business units which focus on patient temperature management (PTM) and single-use endoscopy. TSC Life's PTM business consists of the Mistral Air™ (forced air warming) and Fluido™ (blood and fluid warming) brands. Mistral Air™ holds the number two global market position. The company's endoscopy business is best known for its single-use Broncoflex™ brand, the fastest growing challenger within its space.

From the manufacturer's own website. Source

Information

Country: Netherlands
Address: 48, Bedrijvenpark Twente Noord , Almelo, Netherlands
Website: tsc-life.com
LinkedIn: linkedin.com/company/tsclife
Facebook: —
Email: [email protected]
Phone: +31207902100
PRRC Contact: Federica Federici
EUDAMED SRN: NL-MF-000001973
FDA FEI Number: 3038241934
DUNS Number: —

Catalogue (58)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Mistral-Air® Premium Paediatric Underbody	MA3475	EUDAMEDFDA UDI	Class I	Active
Fluido®Compact Standard Set with drip chamber	672100	EUDAMEDFDA UDI	Class IIa	Active
Mistral-Air® Full Underbody Plus	MA2400	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Full Underbody	MA3400	EUDAMEDFDA UDI	Class I	Active
Fluido® Trauma Set	671500	EUDAMED	Class IIa	Active
Fluido® Irrigation Female Connector	680910	EUDAMED	Class IIa	Active
Mistral-Air® Adult Plus	MA2220	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Half Underbody Plus	MA2450	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Lithotomy Plus	MA2455	EUDAMEDFDA UDI	Class I	Active
Fluido® Compressor	660200A	EUDAMEDFDA UDI	Class I	Active
Fluido® Irrigation URO Male Connection	680805	EUDAMED	Class IIa	Active
Mistral-Air® Upper Body Plus	MA2260	EUDAMEDFDA UDI	Class I	Active
Fluido® Compact Control Module	650100	EUDAMED	Class IIb	Active
Fluido® Trauma Plus Set	671700	EUDAMED	Class IIa	Active
Fluido® Compact Standard Set	672000	EUDAMEDFDA UDI	Class IIa	Active
Mistral-Air® Lower Body Plus	MA2250	EUDAMEDFDA UDI	Class I	Active
Mistral-Air Warming System	K101705	FDA 510(k)	Class II	Active
Fluido Compact Blood and Fluid Warming System	K211618	FDA 510(k)	Class II	Active
Fluido Compact System	K252636	FDA 510(k)	Class II	Active
Mistral-Air® Warming Suit M	MA1720	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Half Underbody	MA3450	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Warming Suit S	MA1710	EUDAMEDFDA UDI	Class I	Active
Fluido® IV-Pole	660500-B	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Torso Plus	MA2270	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Cardiac Plus Sterile	MA2286	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Warming Suit S	MA1610	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Warming Suit M	MA1620	EUDAMEDFDA UDI	Class I	Active
Fluido® Irrigation Catheter Connector	680912	EUDAMED	Class IIa	Active
Fluido® Irrigation Funnel Connector	680913	EUDAMED	Class IIa	Active
Fluido® Standard Set	671200	EUDAMED	Class IIa	Active
Mistral-Air® Premium Warming Suit L	MA1630	EUDAMEDFDA UDI	Class I	Active
Fluido® Irrigation Male Connector	680911	EUDAMED	Class IIa	Active
Mistral-Air® Premium Lithotomy	MA3455	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Surgical Access Plus Sterile	MA2280	EUDAMEDFDA UDI	Class I	Active
Fluido® Air Guard	660400	EUDAMED	Class I	Active
Mistral-Air® Premium Half Upper Body	MA3365	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Half Upper Body Plus	MA2265	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Upper Body	MA3360	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Lower Body	MA3350	EUDAMEDFDA UDI	Class I	Active
Fluido® Compact Holder for Warming Module	660700	EUDAMEDFDA UDI	Class I	Active
Fluido® Pressure Chamber	660300	EUDAMEDFDA UDI	Class IIa	Active
Mistral-Air® Lower Surgical Access Plus Sterile	MA2285	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Warming Suit XL	MA1740	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Tube	MA0510	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Adult	MA3320	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Warming Suit XL	MA1640	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Premium Paediatric	MA3330	EUDAMEDFDA UDI	Class I	Active
Mistral-Air® Warming Suit L	MA1730	EUDAMEDFDA UDI	Class I	Active
Fluido® Compact Warming Module	650200	EUDAMEDFDA UDI	Class IIb	Active
Mistral-Air® Paediatric Underbody Plus	MA2475	EUDAMEDFDA UDI	Class I	Active

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The Surgical Company International B.V. US