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CEFLA S.C.

Italy · Imola

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

15listed device types

Class I 5Class II 9Class III 0unclassified 1

plus 21 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

11active device licences

Class II 5Class III 6

38 including historic records

TWTaiwanTFDA

8valid device licences

Class I 4Class II 4

SGSingaporeHSA SMDR

17device registrations

CLASS B 7CLASS C 10

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

35active ARTG entries

Class I 7IIa 13IIb 15

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States21 registration records, 21 510(k), 0 PMA, 3 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: CEFLA S.C.

FDA 510(k) clearances by year

12008

12010

22013

22015

22016

22017

22019

12020

32022

12023

22024

22026

FDA listed device types

showing 8 of 15

Locator, Root Apex 1System, Image Processing, Radiological 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Device, Pasteurization, Hot Water 1System, X-Ray, Extraoral Source, Digital 1System, X-Ray, Tomography, Computed 1Sterilizer, Steam 1Scaler, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260716	Neowise	2026-05-04
US	K252353	myray ProXIma X6	2026-03-10
US	K230895	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,	2024-04-01
SA	ME0000000521SFDAA00015	myray	—
CA	73113	WDS (WIRELESS DIGITAL SYSTEM)	Class II
CA	75705	S250 NORDAM INTERNATIONAL	Class II
CA	75706	S250 NORDAM CONTINENTAL - DENTAL UNIT	Class II

CEFLA S.C.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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