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 76–100 of 399 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Core 1000	`70ES0000`	`08033837936732`	1	On the market
70ET0000	`70ET0000`	`08033837936749`	1	On the market
97850027, 97850031	`97850027, 97850031`	`08033837932918`	1	On the market
72CC0000, 72CD0000	`72CC0000, 72CD0000`	`08033837933939`	1	On the market
72M90000	`72M90000`	`08033837934912`	1	On the market
701EW001, 701EW051	`701EW001, 701EW051`	`08033837935841`	1	On the market
701EW001, 701EW051	`701EW001, 701EW051`	`08033837936046`	1	On the market
M7E200401, M7E200400, M7E20042, M7E200420, M7E200410	`M7E200401, M7E200400, M7E20042, M7E200420, M7E200410`	`08033837936510`	1	On the market
70EP0000	`70EP0000`	`08033837937173`	1	On the market
70EH0000	`70EH0000`	`08033837936411`	1	On the market
70EG0000	`70EG0000`	`08033837936176`	1	On the market
70EN0000	`70EN0000`	`08033837936794`	1	On the market
70EI0000	`70EI0000`	`08033837936428`	1	On the market
71MH0000	`71MH0000`	`08033837936213`	1	On the market
71MI0000	`71MI0000`	`08033837936220`	1	On the market
76000473	`76000473`	`08033837936527`	1	On the market
76000573	`76000573`	`08033837935278`	1	On the market
76000873	`76000873`	`08033837935292`	1	On the market
76000973	`76000973`	`08033837936602`	1	On the market
76000673	`76000673`	`08033837935285`	1	On the market
76000674	`76000674`	`08033837935315`	1	On the market
76000574	`76000574`	`08033837935308`	1	On the market
76000874	`76000874`	`08033837935322`	1	On the market
76000474	`76000474`	`08033837936541`	1	On the market
76000974	`76000974`	`08033837936619`	1	On the market

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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)
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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)
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