HomeTaiwanCENEFOM CORP.

CENEFOM CORP.

Taiwan · Zhunan Township Miaoli
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia, Israel — 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
6listed device types
Class I 4Class II 2Class III 0
plus 9 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered 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
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 States9 registration records, 0 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Saudi Arabia3 confirmed, 0 excluded
Manufacturer names merged into this page: CENEFOM CORP · CENEFOM CORP. · Cenefom Corp.

Company information

Country
Taiwan
City
Zhunan Township Miaoli

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

Applicator, Absorbent Tipped, Sterile 1Splint, Intranasal Septal 1Gauze/Sponge, Internal, X-Ray Detectable 1Balloon, Epistaxis 1Negative Pressure Wound Therapy Powered Suction Pump 1Sponge, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80148319005Esponjas Oftálmicas EasycareClass II
BR80286920022MICRO ESPONJA OFTALMOLÓGICA PVA CENEFOMClass II
SAME0000006758SFDAA00018Vision
SAME0000006758SFDAA00019Vision

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