HomeItalyLED SpA

LED SpA

Italy · Aprilia (LT) · www.led.it
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Taiwan, Singapore, Australia, Israel, Russia — 7 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
14registered device records
Class I 1Class IIa 2Class IIb 6Custom-made - Class I 1Custom-made - Class IIa 3Custom-made - Class IIb 1
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
7device registrations
CLASS C 7
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 2IIa 1IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 2Class 2b 2
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.

European Union2,294 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States1 registration records, 1 510(k), 0 PMA, 17 excluded
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom14 confirmed, 16 excluded
Brazil0 confirmed, 5 excluded
Canada0 confirmed, 6 excluded
Manufacturer names merged into this page: LED SPA

Regulatory identity

UK responsible person
Maclin Power Ltd
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
Italy
City
Aprilia (LT)
Employees
under 10
Annual revenue
under RMB 5M
Company type
Manufacturer
Website
www.led.it
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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

12022 · K220138

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
UK3537280100.311Custom-made - Class IIa
UK4748700402.00Class IIb
UK4468000201.02Class IIb
USK220138Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP2022-10-05

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