HomeJapanSHOFU INC.

SHOFU INC.

Japan · Kyoto
✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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
24listed device types
Class I 14Class II 10Class III 0
plus 80 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
62registered devices
Class I 11Class II 51
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
13active device licences
Class II 2Class III 11
39 including historic records
TWTaiwanTFDA
42valid device licences
Class I 9Class II 33
SGSingaporeHSA SMDR
19device registrations
CLASS B 19
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
IIa 8
HKHong KongMDACS
6valid listings
Class II 6
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
14active registrations
Class 2a 14
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 States80 registration records, 0 510(k), 0 PMA, 7 excluded
Brazil62 confirmed, 1 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada13 confirmed, 1 excluded
Manufacturer names merged into this page: SHOFU INC.

Company information

Country
Japan
City
Kyoto

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.

Business registration

Corporate Number
6130001009674
Registration status
Active
Registered capital
JPY 5,968,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 24
Sealant, Pit And Fissure, And Conditioner 1Teeth, Porcelain 1Cement, Dental 1Material, Tooth Shade, Resin 1Varnish, Cavity 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1Denture, Plastic, Teeth 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81593399021FL-BOND IIClass II
BR81593399019BEAUTIFIL IIClass II
BR10258190119POLIDORES EM FELTRO SUPER BUFFClass I
SAME0000000746SFDAA00093DirectDia Paste
CA61352TEMPORARY DENTAL CEMENTClass II
CA61521SOLIDEX FINISHING AND POLISHING SYSTEMClass II
CA62374PORCELAIN POWDER - VINTAGE PORCELAINSClass III

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