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 176–200 of 399 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
K50F INTERNATIONAL	`71MK0000`	`08033837936251`	1	On the market
71H10000, 71H40000	`71H10000, 71H40000`	`08033837933212`	1	On the market
71H20000	`71H20000`	`08033837936183`	1	On the market
71H30000	`71H30000`	`08033837933229`	1	On the market
71H50000, 71H80000	`71H50000, 71H80000`	`08033837933243`	1	On the market
71H60000	`71H60000`	`08033837936190`	1	On the market
71H70000	`71H70000`	`08033837933250`	1	On the market
71MU0000	`71MU0000`	`08033837937449`	1	On the market
71MT0000	`71MT0000`	`08033837932864`	1	On the market
71MA0000, 71MN0000, 71NA0000	`71MA0000, 71MN0000, 71NA0000`	`08033837933946`	1	On the market
71MB0000, 71MO0000, 71NB0000	`71MB0000, 71MO0000, 71NB0000`	`08033837933953`	1	On the market
7098M003	`7098M003`	`08033837937135`	1	On the market
NEOWISE	`NEOWISE`	`08033837938835`	1	On the market
P70720008	`P70720008`	`08033837931379`	1	On the market
70V10000	`70V10000`	`08033837932994`	1	On the market
701FW001, 701FW051	`701FW001, 701FW051`	`08033837935780`	1	On the market
NewTom DCiS	`701FW011`	`08033837935797`	1	On the market
NewTom DCiS WL	`701FW001, 701FW051`	`08033837935988`	1	On the market
701FW011	`701FW011`	`08033837935995`	1	On the market
70A40000, 70AD0000	`70A40000, 70AD0000`	`08033837934967`	1	On the market
70A30000, 70AC0000	`70A30000, 70AC0000`	`08033837931898`	1	On the market
70BU0000, 70B6U000	`70BU0000, 70B6U000`	`08033837935520`	1	On the market
70BF0000, 70B2F000	`70BF0000, 70B2F000`	`08033837935582`	1	On the market
70BT0000, 70B6T000	`70BT0000, 70B6T000`	`08033837935551`	1	On the market
70BD0000, 70B2D000	`70BD0000, 70B2D000`	`08033837932949`	1	On the market

6 7 8 9 10

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)
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