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TRISTEL SOLUTIONS LIMITED

United Kingdom (ex Northern Ireland)·GB-MF-000010046

Last updated May 30, 2026

What TRISTEL SOLUTIONS LIMITED makes

Tristel Solutions Limited manufactures medical device disinfection agents, including sporicidal wipes and rinse solutions, as well as test strips designed to verify the effectiveness of disinfection processes. Their portfolio also includes specialized disinfection systems for optical instruments, such as those used in ophthalmology, and automated cleaning and disinfection units for medical devices.

The company’s products are regulated under EU Medical Device Regulations (Class I, IIa, and IIb) and are listed in the EUDAQS database (eudamed), with some devices also authorised via the FDA’s 510(k) and UDI systems in the US. The manufacturer is based in the United Kingdom and operates within global regulatory frameworks for medical device disinfection solutions.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United Kingdom (ex Northern Ireland)
Address: Unit 1b, Lynx Business Park, Snailwell, Cambridgeshire, United Kingdom (ex Northern Ireland)
Website: www.tristel.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +44 (0)1638 721500
PRRC Contact: Katherine Black
EUDAMED SRN: GB-MF-000010046
FDA FEI Number: —
DUNS Number: 235192791

Catalogue (52)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Tristel OPH	Tristel OPH Wipes	FDA UDI	Class II	Active
Tristel OPH	Tristel OPH Foam	FDA UDI	Class II	Active
Tristel ULT	Tristel ULT Foam	FDA UDI	Class II	Active
Tristel ULT	45-25 (case of 2 boxes)	FDA UDI	Class II	Active
Tristel OPH	TSL025126 (case of 2 boxes)	FDA UDI	Class II	Unknown
Tristel Test Strips	45-10	FDA UDI	Class II	Active
Tristel ULT	Tristel ULT Wipes	FDA UDI	Class II	Active
Tristel Test Strips	45-13	FDA UDI	Class II	Active
Tristel Sporicidal Wipes	TSL030201	EUDAMED	Class IIb	Active
Tristel Duo EVE	TSL023001	EUDAMED	Class IIa	Active
Tristel Duo for Rigid Optics	TSL024007	EUDAMED	Class IIb	Active
Tristel Rinse Assure	TSL041901	EUDAMED	Class I	Active
JET LUX (MD and BIO) – BE/FR	CCH010702	EUDAMED	Class IIa	Active
Tristel Clean for Stella	TSL042401	EUDAMED	Class I	Active
Tristel Duo ULT	DEN220041	FDA 510(k)	Class II	Active
Stella System	TSL STELLA - A	EUDAMED	Class IIb	Active
Tristel DUO OPH	TSL022709	EUDAMED	Class IIa	Active
Tristel DUO WIPES	TSL031601	EUDAMED	Class I	Active
JET LUX (MD) 2 x trigger heads	CCH010910	EUDAMED	Class IIa	Active
Tristel Clean for Stella	TSL041001	EUDAMED	Class I	Active
Tristel Duo For Rigid Optics	TSL022507	EUDAMED	Class IIb	Active
Jet Pro	CCH011001	EUDAMED	Class IIa	Active
Tristel DUO OPH	TSL022714	EUDAMED	Class IIa	Active
Tristel Trio Wipes System	TSL030801	EUDAMED	Class IIb	Active
Tristel DUO OPH	TSL023901	EUDAMED	Class IIa	Active
Tristel Trio Wipes System	TSL032001	EUDAMED	Class IIb	Active
Stella System	TSL STELLA - C	EUDAMED	Class IIb	Active
Tristel Trio Wipes System	TSL030601	EUDAMED	Class IIb	Active
Tristel Rinse Assure	TSL RINSE ASSURE 2	EUDAMED	Class I	Active
Duel	CCH040101	EUDAMED	Class IIa	Active
Tristel Pre-Clean Wipe	TSL030401	EUDAMED	Class I	Active
Tristel DUO WIPES	Single Unit	EUDAMED	Class I	Active
Tristel Pre-Clean Wipes	TSL030409	EUDAMED	Class I	Active
Jet	CCH010501	EUDAMED	Class IIa	Active
Duel	CCH040101	EUDAMED	Class IIa	Active
JET LUX (MD and BIO) - EN	CCH010701	EUDAMED	Class IIa	Active
Tristel VISICLEAN	FOAMER014	EUDAMED	Class I	Active
Pod Clo2 10+5	CCH070301	EUDAMED	Class IIa	Active
Tristel DUO OPH	TSL022701, TSL023901	EUDAMED	Class IIa	Active
Tristel CLEAN	Single unit	EUDAMED	Class I	Active
Pod Clo2 5	CCH071001	EUDAMED	Class IIa	Active
Stella System	TSL STELLA - B	EUDAMED	Class IIb	Active
Enzystel	MD315	EUDAMED	Class I	Active
Tristel Fuse for Stella	TSL010610	EUDAMED	Class IIb	Active
Jet	CCH010101	EUDAMED	Class IIa	Active
JET LUX (MD) – Recharge pack 0 trigger heads	CCH011310	EUDAMED	Class IIa	Active
Tristel Fuse for Stella	TSL010701	EUDAMED	Class IIb	Active
Tristel Rinse Wipes	TSL030301	EUDAMED	Class I	Active
Tristel Fuse For Stella	TSL010601	EUDAMED	Class IIb	Active
Tristel Rinse Wipes	TSL030309	EUDAMED	Class I	Active

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Tristel NV BE

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