HomeSingaporeINNOVEX MEDICAL TECHNOLOGY PTE. LTD

INNOVEX MEDICAL TECHNOLOGY PTE. LTD

Singapore · Singapore · www.innovexsg.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000015981

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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
≥300UDI-DI device records
Class I 14Class IIa 286
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
5listed device types
Class I 1Class II 4Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
12registered device records
Class I 3Class IIa 9
BRBrazilANVISA
11registered devices
Class II 11
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
19 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
IIa 2Class Is (sterile) 4
HKHong KongMDACS
1valid listings
Class II 1
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.

European Union352 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States5 registration records, 0 510(k), 0 PMA, 1 excluded
United Kingdom12 confirmed, 0 excluded
Brazil11 confirmed, 0 excluded
Manufacturer names merged into this page: INNOVEX MEDICAL CO., LTD. · INNOVEX MEDICAL CO.

Regulatory identity

EU manufacturer SRN
CN-MF-000015981
EU authorised representative
Emergo Europe B.V.
UK responsible person
Emergo Consulting (UK) Limited

Company information

Country
Singapore
City
Singapore
Website
www.innovexsg.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1Endoscopic Access Overtube, Gastroenterology-Urology 1Bottle, Collection, Vacuum 1Dislodger, Stone, Flexible 1Stylet, Ureteral 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06950203355022Class I
EU06950203341292Class IIa
EU06950203341131Class IIa
EU06950203341056Class IIa
UK46452Urological Stone Extraction BasketsClass IIa
UK38821Ureteral CathetersClass IIa
UK38821Ureteral CathetersClass IIa
BR80102519295CESTOS PARA EXTRAÇÃO DE CÁLCULOS UROLÓGICOS DORNIERClass II
BR80082919050FRASCO COLETOR UROPRIME TAIMINClass II
BR80082919063CATETER URETERAL ANTIRREFLUXO UROPRIME TAIMINClass II

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