HomeChinaWingderm Electro-Optics , Ltd.

Wingderm Electro-Optics , Ltd.

China · Beijing
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Australia, Israel, Russia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 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 States3 registration records, 3 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: WINGDERM ELECTRO-OPTICS LTD.

Company information

Country
China
City
Beijing

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

12019 · K191611
12020 · K192350
12026 · K252599

FDA listed device types

Powered Laser Surgical Instrument 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252599Diode Laser Therapy Systems (WLA-02)2026-02-24
USK192350Medical Non-Ablative Fractional Laser Systems2020-04-30
USK191611Diode Laser Therapy Systems2019-07-31
BR82349819001MESOJECT GUNClass II

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