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CEFLA s.c.

Italy·IT-MF-000009228

Last updated September 17, 2026

Information

Country: Italy
Address: 23/A, Via Selice Provinciale, Imola, Italy
Website: www.cefla.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +39 0 542 65 31 11
PRRC Contact: Silvia Montosi
EUDAMED SRN: IT-MF-000009228
FDA FEI Number: 3006610845
DUNS Number: —

Catalogue (318)

Page 3 of 7

Device	Model / Reference	Registries	Class	Status
C-22 Platinum	7AC41xxx	EUDAMED	Class IIb	Active
Sw-22 S	7AS01xxx	EUDAMED	Class IIb	Active
B Now-22	7AM31xxx	EUDAMED	Class IIb	Active
Sw-22	7AS11xxx	EUDAMED	Class IIb	Active
Goldspeed Evo D1	76000573	EUDAMED	Class IIa	Active
Sw-28 Plus	7AS22xxx	EUDAMED	Class IIb	Active
Bravo G4 22	7A621000, 7A621010, 7A621020, 7A621030	EUDAMED	Class IIb	Active
ZEN-X DCiS	701AW011	EUDAMED	Class IIa	Active
Goldspeed Evo S1-L	76000571	EUDAMED	Class IIa	Active
S4x-28	7AP22000, 7AP22005	EUDAMED	Class IIb	Active
A-22t	7AA31xxx	EUDAMED	Class IIb	Active
X-Vs E	701X0001, 701X0002, 701XA000	EUDAMED	Class IIa	Active
i-MMr	95520602, 95520669	EUDAMED	Class IIa	Active
ViSIOScan WR	7098N002	EUDAMEDFDA UDI	Class I	Active
S Classic-17	7AM00xxx	EUDAMED	Class IIb	Active
Sw-22 Plus	7AS21xxx	EUDAMED	Class IIb	Active
A-17 Platinum	7AA40xxx	EUDAMED	Class IIb	Active
K 7.5 T	7AK31xxx	EUDAMED	Class IIb	Active
C-17 Plus	7AC20xxx	EUDAMED	Class IIb	Active
X-VSi	701Q0000, 701Q0001	EUDAMED	Class IIa	Active
C-22 S	7AC01xxx	EUDAMED	Class IIb	Active
X-ViSUS DCiS	701BW011	EUDAMED	Class IIa	Active
i-MMs	95520443, 95520662	EUDAMEDFDA UDI	Class IIa	Active
Family of Steam sterilizers B17 B22 Series	K161848	FDA 510(k)	Class II	Active
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	K214084	FDA 510(k)	Class II	Active
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	K223794	FDA 510(k)	Class II	Active
Myray- HYPERION X5	K152162	FDA 510(k)	Class II	Active
myray ProXIma X6	K252353	FDA 510(k)	Class II	Active
Apex Locator	K231990	FDA 510(k)	U	Active
Family of Steam Sterilizers B 28 series	K151597	FDA 510(k)	Class II	Active
R7	K130834	EUDAMEDFDA 510(k)	Class II	Active
Myray Skyview	K081088	FDA 510(k)	Class II	Active
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	K190496	FDA 510(k)	Class II	Active
S200, S300	K133412	FDA 510(k)	Class I	Active
Stern's S250 Nordam	K092917	FDA 510(k)	Class I	Active
Venus Plus	96601060, 96601071	EUDAMED	Class I	Active
MyScan WL	7098M003	EUDAMED	Class I	Active
X-Neo	70A70000, 70AG0000	EUDAMED	Class IIb	Active
i-MMr L	95520603, 95520670	EUDAMED	Class IIa	Active
OptiSCAN WL	7098B003	EUDAMED	Class I	Active
Goldspeed Evo S1	76000470	EUDAMED	Class IIa	Active
A-28 Plus	7AA22xxx	EUDAMED	Class IIb	Active
C-28t	7AC32xxx	EUDAMED	Class IIb	Active
Sw-22t	7AS31xxx	EUDAMED	Class IIb	Active
NewTom 5G XL	P70720008	EUDAMEDFDA UDI	Class IIb	Active
handy POWER LED FLUO	95520676	EUDAMED	Class IIa	Active
K 6.0 T	7AK30xxx	EUDAMED	Class IIb	Active
ProXIma X6	70EK0000	EUDAMED	Class IIb	Active
Sw-17	7AS10xxx	EUDAMED	Class IIb	Active
i-XS4	95520445, 95520665	EUDAMEDFDA UDI	Class IIa	Active

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