HomeTaiwanUnimax Medical Systems Inc.

Unimax Medical Systems Inc.

Taiwan · New Taipei City · www.unimaxmeds.com
✓ Record-verifiedregistrations found in 11 marketsEU SRN TW-MF-000008895

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 11 overseas markets. EU UDI-DI records ≥198, 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
pendingnot queried
EUEuropean UnionEUDAMED
≥198UDI-DI device records
Class I 13Class IIa 144Class IIb 41
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
13listed device types
Class I 5Class II 8Class III 0
plus 29 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
21registered device records
Class I 3Class IIa 12Class IIb 6
BRBrazilANVISA
25registered devices
Class I 2Class II 23
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
15active device licences
Class II 15
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
7device registrations
CLASS B 6CLASS C 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
39active ARTG entries
Class I 2IIa 23IIb 11Class Is (sterile) 3
HKHong KongMDACS
5valid listings
Class II 3Class III 2
ILIsraelAMAR
6registrations
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 Union348 raw hits, 102 excluded, 198 confirmed. Large result set — only the first 300 verified
United States29 registration records, 7 510(k), 0 PMA, 2 excluded
United Kingdom21 confirmed, 1 excluded
Brazil25 confirmed, 2 excluded
Saudi Arabia2 confirmed, 1 excluded
Canada15 confirmed, 0 excluded
Manufacturer names merged into this page: UNIMAX MEDICAL SYSTEMS INC. · UNIMAX MEDICAL SYSTEMS, INC. · Unimax Medical Systems Inc.

Regulatory identity

EU manufacturer SRN
TW-MF-000008895
EU authorised representative
mdi Europa GmbH
UK responsible person
Qserve Group UK, Ltd.

Company information

Country
Taiwan
City
New Taipei City
Website
www.unimaxmeds.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 510(k) clearances by year

62011 · K103508
12021 · K211577

FDA listed device types

showing 8 of 13
Electrosurgical, Cutting & Coagulation & Accessories 1Catheter And Tip, Suction 1Pneumoperitoneum Needle 1Anti Fog Solution And Accessories, Endoscopy 1Bottle, Collection, Vacuum 1Ring (Wound Protector), Drape Retention, Internal 1Laparoscope, General & Plastic Surgery 1Insufflator, Laparoscopic 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04714127860213Class IIa
EU04714127860237Class IIa
EU04714127860206Class IIa
EU04714127860220Class IIa
UK47143Monopolar CordClass I
UK45225Anti fogClass IIa
UK61875Monopolar electrodeClass IIb
USK211577SoftFix Balloon Trocar2021-11-05
USK103508UNMIAX LAPAROSCOPIC INSTRUMENT2011-12-20
USK112358UNIMAX TROCAR SYSTEM2011-10-17
BR80459130043Kit para Sução e IrrigaçãoClass II
BR80037520035INSTRUMENTOS DESCARTÁVEIS PARA LAPAROSCOPIA - TESOURA MONOPOLARClass II
BR80984190023Cânula para Insuflação Tipo VeressClass II
SAME0000004316SFDAA00002Reusable Clip Applier
SAME0000004543SFDAA00006Reusable Clip Remover
CA86170SUCTION IRRIGATION SYSTEMClass II
CA86209CAMERA SLEEVEClass II
CA86246INSUFFLATION TUBING SETClass II

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