HomeChinaPREMIUM PLUS (DONGGUAN) LIMITED

PREMIUM PLUS (DONGGUAN) LIMITED

China · Dongguan Guangdong
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Australia — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
79listed device types
Class I 61Class II 18Class III 0
plus 145 registration records and 7 510(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
5valid device licences
Class I 4Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
35active ARTG entries
Class I 31IIa 4
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 States145 registration records, 7 510(k), 0 PMA, 9 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: PREMIUM PLUS DENTAL SUPPLIES INC · PREMIUM PLUS (DONGGUAN) LIMITED · Premium Plus International Limited
Same-named companies — This database also contains companies with near-identical names: PREMIUM PLUS DENTAL SUPPLIES INC, Premium Plus International Limited. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Dongguan Guangdong

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

12010 · K100854
12016 · K153514
22017 · K170261
12022 · K220662
22025 · K251869

FDA listed device types

showing 8 of 79
Container, Sharps 1Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Indicator, Physical/Chemical Sterilization Process 1Tester, Pulp 1Wrap, Sterilization 1Syringe, Piston 1Syringe, Antistick 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)2025-09-15
USK250009LED Curing Light (C01-X, C02-X)2025-04-10
USK220662Disposable Barrier Sleeves2022-05-11

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