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Home›Italy›EL.EN. ELECTRONIC ENGINEERING SPA

EL.EN. ELECTRONIC ENGINEERING SPA

Italy · Calenzano Firenze
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
13listed device types
Class I 1Class II 12Class III 0
plus 47 registration records and 44 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 States47 registration records, 44 510(k), 0 PMA, 4 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia0 confirmed, 2 excluded
Manufacturer names merged into this page: EL.EN. ELECTRONIC ENGINEERING SPA · EL.EN. S.P.A. · EL EN S.P.A.
Same-named companies — This database also contains companies with near-identical names: EL.EN. S.P.A.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Italy
City
Calenzano Firenze

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22007
22009
22011
32013
12014
12015
32017
42018
22019
12020
62021
12022
62023
62024
32025
12026

FDA listed device types

showing 8 of 13
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Lamp, Infrared, Therapeutic Heating 1Stimulator, Muscle, Powered 1Electrosurgical, Cutting & Coagulation & Accessories 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Massager, Vacuum, Radio Frequency Induced Heat 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260647SPECCHIO2026-04-02
USK251432Olo2025-08-06
USK243683Deka Bluebeam2025-06-12

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