Statistics for CEFLA s.c.

399Total Devices

21Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for CEFLA s.c.

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for CEFLA s.c.

Showing 151–175 of 399 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
95520454, 95520663	`95520454, 95520663`	`08033837930723`	1	On the market
95520437, 95520664	`95520437, 95520664`	`08033837930730`	1	On the market
95520674	`95520674`	`08033837935919`	1	On the market
95520445, 95520665	`95520445, 95520665`	`08033837930747`	1	On the market
95520675	`95520675`	`08033837935902`	1	On the market
95520441, 95520668	`95520441, 95520668`	`08033837930402`	1	On the market
95520677	`95520677`	`08033837935926`	1	On the market
7AK10xxx	`7AK10xxx`	`08033837938156`	1	On the market
7AK40xxx	`7AK40xxx`	`08033837938248`	1	On the market
7AK20xxx	`7AK20xxx`	`08033837938187`	1	On the market
7AK00xxx	`7AK00xxx`	`08033837938125`	1	On the market
7AK30xxx	`7AK30xxx`	`08033837938217`	1	On the market
7AK11xxx	`7AK11xxx`	`08033837938163`	1	On the market
7AK41xxx	`7AK41xxx`	`08033837938255`	1	On the market
7AK21xxx	`7AK21xxx`	`08033837938194`	1	On the market
7AK01xxx	`7AK01xxx`	`08033837938132`	1	On the market
7AK31xxx	`7AK31xxx`	`08033837938224`	1	On the market
7AK12xxx	`7AK12xxx`	`08033837938170`	1	On the market
7AK42xxx	`7AK42xxx`	`08033837938262`	1	On the market
7AK22xxx	`7AK22xxx`	`08033837938200`	1	On the market
7AK02xxx	`7AK02xxx`	`08033837938149`	1	On the market
7AK32xxx	`7AK32xxx`	`08033837938231`	1	On the market
71ME0000, 71MR0000	`71ME0000, 71MR0000`	`08033837934004`	1	On the market
71MF0000, 71MS0000	`71MF0000, 71MS0000`	`08033837934011`	1	On the market
K50F CONTINENTAL	`71MJ0000`	`08033837936244`	1	On the market

5 6 7 8 9

Market presence of CEFLA s.c.

Devices placed in 1 country

Italy399

EUDAMED update: Mar 4, 2025

CEFLA s.c.

IT-MF-000009228

Active

Address: Via Selice Provinciale, 23/A 40026 Imola
Role: Manufacturer
Date of registration: Jul 5, 2021
Country: IT Italy

About CEFLA s.c.

SRN: IT-MF-000009228
Role: Manufacturer
Country: Italy
Organization name: CEFLA s.c.
EU VAT number: IT00499791200
EORI: IT00499791200
Date of registration: Jul 5, 2021

Contact details for CEFLA s.c.

Address: 23/A, VIA SELICE PROVINCIALE 40026 IMOLA ITALY
Phone: +39 0 542 65 31 11
Email: ceflaimola@cefla.it
Website: www.cefla.com/

Validator

Name: Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico
SRN: IT-CA-070
Phone: +39 06 5994 3199/ +39 06 5994 3207
Email: segr.dgfdm@sanita.it

Officers and regulatory representatives of CEFLA s.c.

MONTOSI Silvia
• Ensure that the reporting obligations of art. 87 to 91 are met by monitoring the QMS • Ensure that PMS obligations of art. 10, par. 10 are met by collecting data on the quality, performance and safety of devices; ensuring implementation and monitoring any necessary actions; • Ensure that the reporting obligations of art. 87 to 91 are met with regard to: Collection and analysis of reports of serious accidents (art. 87); Collection and analysis of data to generate trend reports (art. 88)
Hidden
MONTOSI Silvia
• Ensure drafting of technical documentation and EU declaration of conformity • Ensure that obligations arising from PMS of art. 10 par. 10 are met with regard to technical documentation • Perform the registration of Cefla in Eudamed (art. 31 point 5). • Ensure timely updates on EUDAMED related to: all serious accident reports (art. 87); trend reports (art. 88); device registration (art. 29 point 4); PSURs; Safety Warnings (art. 89) • Ensure the compliance of devices before release
Hidden
PORISINI Agnese
• Ensure that the reporting obligations of art. 87 to 91 are met by monitoring the QMS • Ensure that PMS obligations of art. 10, par. 10 are met by collecting data on the quality, performance and safety of devices; ensuring implementation and monitoring any necessary actions; • Ensure that the reporting obligations of art. 87 to 91 are met with regard to: Collection and analysis of reports of serious accidents (art. 87); Collection and analysis of data to generate trend reports (art. 88)
Hidden