HomeKorea, RepublicSurginus Co., Ltd.

Surginus Co., Ltd.

Korea, Republic · Daejeon · www.surginus.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN KR-MF-000035779

This company has registrations in European Union, United States, Brazil, Taiwan, Israel — 5 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
14UDI-DI device records
Class IIa 14
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
3registered devices
Class II 3
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
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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.

European Union14 raw hits, 0 excluded, 14 confirmed
United States4 registration records, 0 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: SURGINUS CO.,LTD. · SURGINUS CO. LTD

Regulatory identity

EU manufacturer SRN
KR-MF-000035779
EU authorised representative
Javitech Consulting GmbH
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
Korea, Republic
City
Daejeon
Employees
10–50
Annual revenue
under RMB 5M
Company type
Manufacturer
Website
www.surginus.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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

Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use 1System, Skin Closure 1Dressing, Wound, Hydrophilic 1First Aid Kit Without Drug 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08800106200074Class IIa
EU08800106200081Class IIa
EU08800106200098Class IIa
EU08800106200104Class IIa
BR10242789002COMPRESSÃO DE SUTURA SURGINUSClass II
BR80203029008Sutura de Compressão Cutânea KlosureClass II
BR10242789003SURTURYClass II

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