HomeTaiwanOMNIMATE ENTERPRISE CO., LTD.

OMNIMATE ENTERPRISE CO., LTD.

Taiwan · Ilan County Yilan
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, South Korea, Russia — 4 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
15listed device types
Class I 12Class II 3Class III 0
plus 15 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 1 1Class 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 States15 registration records, 0 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: OMNIMATE ENTERPRISE CO., LTD. · OMNIMATE ENTERPRISE CO. LTD

Company information

Country
Taiwan
City
Ilan County Yilan

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 listed device types

showing 8 of 15
Mask, Gas, Anesthetic 1Stylet, Tracheal Tube 1Endoscopic Bite Block 1Mask, Oxygen, Non-Rebreathing 1Connector, Airway (Extension) 1Cannula, Nasal, Oxygen 1Scalpel, One-Piece 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80171530096Máscara Laríngea Descartável NewMedClass II
BR80171530097Máscara Laríngea Reutilizável NewMedClass II
BR80281070079Máscara de Coxim InflávelClass II

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