HomeJapanAlfresa Pharma Corporation

Alfresa Pharma Corporation

Japan · Osaka
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Hong Kong, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(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
3active device licences
Class II 3
5 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
IVD import 3
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
IVD C 1
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
20active registrations
Class 1 2Class 2a 13Class 2b 4Class 3 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 States1 registration records, 0 510(k), 0 PMA
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: Alfresa Pharma Corporation · ALFRESA PHARMA CORPORATION

Company information

Country
Japan
City
Osaka

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

Toothbrush, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
CA86939I-FOBT TRANSFERRIN NS-PLUSClass II
CA87096I-FOBT TRANSFERRIN NS-PLUS CALIBRATORClass II
CA84298I-FOBT HEMOGLOBIN NS-PLUSClass II

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