HomeTaiwanNORTH EOS INDUSTRIES, INC.

NORTH EOS INDUSTRIES, INC.

Taiwan · Taichung Hsien
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, 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
22listed device types
Class I 18Class II 4Class III 0
plus 22 registration records and 3 510(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
1active device licences
Class II 1
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 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 States22 registration records, 3 510(k), 0 PMA, 5 excluded
Brazil0 confirmed, 2 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: NORTH EOS INDUSTRIES, INC.

Company information

Country
Taiwan
City
Taichung Hsien

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

31996 · K963685

FDA listed device types

showing 8 of 22
Sound, Uterine 1Curette, Nasal 1Illuminator, Color Vision Plate 1Remover, Intrauterine Device, Contraceptive, Hook-Type 1Dilator, Nasal 1Accessories, Retractor, Dental 1Gag, Mouth 1Speculum, Rectal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK963685EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER1996-10-11
USK963377EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC1996-10-04
USK954614EOS BRAND DISPOSABLE PROCTOSCOPE1996-04-10
CA75510EYELIDSPECClass II

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