HomeUSAHu-Friedy Mfg. Co., Inc.

Hu-Friedy Mfg. Co., Inc.

USA · Chicago
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
78listed device types
Class I 66Class II 12Class III 0
plus 231 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
19registered devices
Class I 17Class II 2
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
29 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States231 registration records, 9 510(k), 0 PMA
Brazil19 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: HU-FRIEDY MFG CO., LLC · HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC · HU-FRIEDY MFG. CO. LLC · HU-FRIEDY MFG. CO., LLC · HU-FRIEDY MFG. CO. INC. ALSO DBA EI · HU-FRIEDY MANUFACTURING CO. INC
Same-named companies — This database also contains companies with near-identical names: HU-FRIEDY MANUFACTURING CO. INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Chicago

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

11984
11991
11995
12001
12006
12007
12008
12010
12012

FDA listed device types

showing 8 of 78
Indicator, Physical/Chemical Sterilization Process 1Suture, Nonabsorbable, Synthetic, Polypropylene 1Suture, Nonabsorbable, Silk 1Wrap, Sterilization 1Suture, Absorbable, Natural 1Indicator, Biological Sterilization Process 1Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene 1Scaler, Ultrasonic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK120659HU-FRIEDY DENTAL CARTRIDGE SYRINGE2012-11-06
USK100401SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM2010-03-30
USK073369EI DOWNPAK BARRIER SLEEVES2008-02-27
BR80422630017IMPLACARE HU-FRIEDYClass I
BR80422630016PONTA DE ULTRA-SOM ODONTOLÓGICO HU-FRIEDYClass II
BR80422630003INSTRUMENTOS CIRÚRGICOS ODONTOLÓGICOS HU-FRIEDYClass I
CA74045DOWNPAK CORDLESS OBTURATOR DEVICE SYSTEMClass II

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