HomeChinaEXACT MEDICAL MANUFACTURING, INC.

EXACT MEDICAL MANUFACTURING, INC.

China · Changzhou Jiangsu
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
17listed device types
Class I 10Class II 7Class III 0
plus 47 registration records and 9 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
15active ARTG entries
Class I 2Class Is (sterile) 13
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
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 States47 registration records, 9 510(k), 0 PMA, 9 excluded
Brazil1 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: EXACT MEDICAL MANUFACTURING, INC. · EXACT MEDICAL MANUFACTURING INC

Company information

Country
China
City
Changzhou Jiangsu

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

42010 · K101598
12011 · K111535
12012 · K120045
12013 · K121919
12021 · K211969
12023 · K222460

FDA listed device types

showing 8 of 17
Gown, Surgical 1Transducer, Ultrasonic, Diagnostic 1Wrap, Sterilization 1Drape, Surgical, Exempt 1Autofluorescence Imaging Adjunct Tool For Wounds 1Drape, Surgical, Antimicrobial 1Tubing, Noninvasive 1Syringe, Irrigating (Non Dental) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222460Intraoperative Ultrasound Probe Cover2023-05-12
USK211969EMM Ultrasonic Transducer Cover2021-08-13
USK121919SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV2013-02-14
BR81668620008Capa protetora estéril ConfianzzaClass I

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