HomeTaiwanMem Dental Technology Co., Ltd.

Mem Dental Technology Co., Ltd.

Taiwan · Tainan
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Singapore, 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
10listed device types
Class I 8Class II 2Class III 0
plus 10 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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.

United States10 registration records, 2 510(k), 0 PMA, 2 excluded
Brazil0 confirmed, 2 excluded
Manufacturer names merged into this page: MEM DENTAL TECHNOLOGY CO LTD

Company information

Country
Taiwan
City
Tainan

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 · K180952
12025 · K242637

FDA listed device types

showing 8 of 10
Spring, Orthodontic 1Band, Preformed, Orthodontic 1Clamp, Wire, Orthodontic 1Plier, Orthodontic 1Tube, Orthodontic 1Bracket, Metal, Orthodontic 1Band, Elastic, Orthodontic 1Wire, Orthodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242637MEM Clear Aligner System2025-05-21
USK180952Ceramic Bracket2019-06-07

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