HomeUSAPRO-DEX, INC.

PRO-DEX, INC.

USA · Irvine
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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
9listed device types
Class I 6Class II 3Class III 0
plus 18 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
2active device licences
Class II 2
12 including historic records
TWTaiwanTFDA
2valid device licences
Class I 1Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
7active ARTG entries
Class I 1IIa 3Class Is (sterile) 3
HKHong KongMDACS
1valid listings
Class II 1
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 States18 registration records, 0 510(k), 0 PMA, 4 excluded
Brazil0 confirmed, 1 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: PRO-DEX, INC. · Pro-Dex Inc

Company information

Country
USA
City
Irvine

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

Legal name
PRO DEX INC
CIK
0000788920
Registration status
Active
Listing status
Listed (PDEX)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 9
Motor, Surgical Instrument, Ac-Powered 1Bit, Surgical 1Screwdriver, Skullplate 1Tray, Surgical, Instrument 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1Scaler, Periodontic 1Orthopedic Stereotaxic Instrument 1Arthroscope 1

Registration details (sample)

MarketIdentifierNameClass / date
CA77981DYNATORQ ENDODONTIC SYSTEMClass II
CA77982INTRAFLOW HTP ANESTHESIA DELIVERY SYSTEMClass II

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