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Home›USA›QUEST MEDICAL, INC.

QUEST MEDICAL, INC.

USA · Allen
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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
22listed device types
Class I 8Class II 13Class III 0unclassified 1
plus 33 registration records and 41 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
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
8active device licences
Class II 8
28 including historic records
TWTaiwanTFDA
4valid device licences
Class I 3Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States33 registration records, 41 510(k), 0 PMA, 12 excluded
Brazil1 confirmed, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada8 confirmed, 3 excluded
Manufacturer names merged into this page: QUEST MEDICAL, INC. · QUEST MEDICAL IMAGING · QUEST MEDICAL, INC
Same-named companies — This database also contains companies with near-identical names: QUEST MEDICAL IMAGING. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Allen

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

11983
21984
11985
11986
11994
51995
21996
11997
22000
12001
22004
22012
32015
12016
12017
22018
22020
12021
22022
12024

FDA listed device types

showing 8 of 22
Stand, Infusion 1Administration Set Securement Device 1Hook, Ophthalmic 1Probe, Lachrymal 1Device, Intravascular Catheter Securement 1Snare, Surgical 1Dilator, Lachrymal 1Instruments, Surgical, Cardiovascular 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241058Lyka® PORT Needle Free Access Device (4170Y)2024-12-18
USK213846Q2 Blood Administration Sets2022-06-05
USK213588Q2 IV Administration Sets2022-06-02
BR80136999017SafeflowClass I
CA8744TRIPPLE ACTION VACUUN RELIEF VALVEClass II
CA8746RETRACT-O-TAPE VASCULAR LOOPClass II
CA8747PRESSURE MONITOR SEPARATORClass II

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