HomeChinaSURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.

SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.

China · Cixi City
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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
8listed device types
Class I 0Class II 7Class III 0unclassified 1
plus 7 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
8 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
IIb 4
HKHong KongMDACS
8valid listings
Class II 1Class III 7
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
5active registrations
Class 2b 5
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 States7 registration records, 7 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO. LTD

Company information

Country
China
City
Cixi City

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

22019 · K183153
22021 · K210488
12022 · K212614
12023 · K221995
12024 · K240376

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Low Energy Direct Current Thermal Ablation System 1Laparoscope, Gynecologic (And Accessories) 1Laparoscope, General & Plastic Surgery 1Ureteroscope And Accessories, Flexible/Rigid 1System, Ablation, Microwave And Accessories 1Insufflator, Laparoscopic 1Instrument, Ultrasonic Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240376Electroporation System (N3000)2024-10-04
USK221995Gas Insufflator2023-03-28
USK212614Ultrasonic Scalpel System2022-07-18
BR80102519133Insuflador de gásClass II
BR80102519199InflaCure™ Conjunto de Tubos de InsuflaçãoClass II

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