HomeKorea, RepublicLAMEDITECH Co., Ltd.

LAMEDITECH Co., Ltd.

Korea, Republic · Seoul · www.lameditech.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN KR-MF-000007869

This company has registrations in European Union, United States, United Kingdom, Taiwan, Israel, Russia — 6 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
3UDI-DI device records
Class IIa 3
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 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
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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.

European Union3 raw hits, 0 excluded, 3 confirmed
United States1 registration records, 1 510(k), 0 PMA
United Kingdom1 confirmed, 0 excluded
Manufacturer names merged into this page: LAMEDITECH CO., LTD.

Regulatory identity

EU manufacturer SRN
KR-MF-000007869
EU authorised representative
Obelis s.a.
UK responsible person
Medenico Ltd

Company information

Country
Korea, Republic
City
Seoul
Website
www.lameditech.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsPoint-of-care & near-patient testing

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

12018 · K172818

FDA listed device types

Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08800031600062HandyRay-ProClass IIa
EU08800031600086HandyRay-LiteClass IIa
EU08800031600079CAREVEAMClass IIa
UK66537HandyRay-LiteClass IIa
USK172818LMT-30002018-03-07

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