HomeKorea, RepublicZERONE CO., LTD.

ZERONE CO., LTD.

Korea, Republic · Gunpo-si Gyeonggi-do · www.01zeus.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN KR-MF-000014148

This company has registrations in European Union, United Kingdom, Brazil, Taiwan, Australia, Israel, Russia — 7 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
50UDI-DI device records
Class IIa 16Class IIb 34
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIb 1
BRBrazilANVISA
4registered devices
Class II 4
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
5valid device licences
Class II 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
6active registrations
Class 2a 4Class 2b 2
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 Union50 raw hits, 0 excluded, 50 confirmed
United Kingdom1 confirmed, 0 excluded
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: ZERONE CO., LTD.

Regulatory identity

EU manufacturer SRN
KR-MF-000014148
EU authorised representative
CMC Medical Devices & Drugs SL
UK responsible person
OscarTech Uk Ltd

Company information

Country
Korea, Republic
City
Gunpo-si Gyeonggi-do
Website
www.01zeus.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instrumentsAnaesthesia, intensive care & life-support systemsCardiology & vascular medicine

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.

Registration details (sample)

MarketIdentifierNameClass / date
EU08809417421017Ultrasonic Surgical UnitClass IIb
EU08809417420300Electrosurgical UnitClass IIb
EU08809417420218Electrosurgical UnitClass IIb
EU08809417420195Electrosurgical UnitClass IIb
UK44776Zerone Electrosurgical unitClass IIb
BR82428799002TROCARTE DESCARTÁVEL SEM LÂMINATROPIANClass II
BR82428799003TROCARTE DESCARTÁVEL SEM LÂMINA PORTA ÚNICA TROPIANClass II
BR82428799004TROCARTE DESCARTÁVEL TROPIAN SEM LÂMINA COM FILTROClass II

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