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Home›Czech Republic›NOVANTA MEDICAL S.R.O.

NOVANTA MEDICAL S.R.O.

Czech Republic · Prelouc Pardubicky Kraj
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
14listed device types
Class I 7Class II 7Class III 0
plus 76 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
5active device licences
Class II 5
16 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 States76 registration records, 0 510(k), 0 PMA
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: Novanta Medical GmbH · NOVANTA MEDICAL S.R.O. · NOVANTA MEDICAL GMBH
Same-named companies — This database also contains companies with near-identical names: Novanta Medical GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Czech Republic
City
Prelouc Pardubicky Kraj

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 listed device types

showing 8 of 14
Insufflator, Endoscopic Vessel Harvesting 1Arthroscope 1Insufflator, Hysteroscopic 1Laparoscope, Gynecologic (And Accessories) 1Cover, Barrier, Protective 1Laparoscope, General & Plastic Surgery 1Insufflator, Laparoscopic 1Tubing/Tubing With Filter, Insufflation, Laparoscopic 1

Registration details (sample)

MarketIdentifierNameClass / date
CA603040L HIGH FLOW INSUFFLATORClass II
CA82975GAMMA FINDER G100Class II
CA91480FLUID MANAGEMENT SYSTEM H112/M112Class II

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