Question 1

What does STEELCO S.P.A. manufacture?

Accepted Answer

STEELCO S.P.A. manufactures surgical utensil washers/disinfectors and steam sterilizers, including models such as the Endoscope Washer, VS 8/2, Steelco VS Series Steam Sterilizers, ETD Mini, TW 3000/2, DS 1000 3S, DS 610 SL G2, and EW 1.

Question 2

Where is STEELCO S.P.A. based?

Accepted Answer

STEELCO S.P.A. is based in Italy, as indicated by the country code IT in their device registration information.

Question 3

Which regulatory registries list STEELCO S.P.A.'s devices?

Accepted Answer

STEELCO S.P.A.'s devices are listed in the eudamed and fda_510k registries, which are European and US regulatory databases for medical devices respectively.

Question 4

How are STEELCO S.P.A.'s devices classified?

Accepted Answer

STEELCO S.P.A.'s devices are classified into Class I, Class II, and Class IIb, which represent different levels of regulatory control based on the potential risks associated with each device type.

Device	Model / Reference	Registries	Class	Status
Dryers	ED 250/1, ED 250/2, ED 250/3, ED 250/4	EUDAMED	Class I	Active
Endoscope Washer	EPW 100 S	EUDAMED	Class I	Active
Vs 8/2	99VS08PED 0001	EUDAMED	Class IIb	Active
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869	K213545	FDA 510(k)	Class II	Active
ETD Mini	9968024	EUDAMED	Class IIb	Active
Tw 3000/2	9979008	EUDAMED	Class IIb	Active
Tw 3000/2	9979018	EUDAMED	Class IIb	Active
Tw 3000/2	9979015	EUDAMED	Class IIb	Active
Tw 3000/2	9979004	EUDAMED	Class IIb	Active
Ds 1000 3s	DS 1000 3S	EUDAMED	Class IIb	Active
Tw 3000/2	9979007	EUDAMED	Class IIb	Active
Ds 610 Sl G2	DS 610 SL G2	EUDAMED	Class IIb	Active
Tw 3000/2	9979014	EUDAMED	Class IIb	Active
Tw 3000/2	9979027	EUDAMED	Class IIb	Active
Ew 1	9968032	EUDAMED	Class IIb	Active
Tw 3000/2	9979023	EUDAMED	Class IIb	Active

STEELCO S.P.A.

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