HomeKorea, RepublicRecensmedical, Inc.

Recensmedical, Inc.

Korea, Republic · Hwaseong-Si Gyeonggi
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel — 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
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 1Class III 0unclassified 2
plus 3 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
1valid listings
Class II 1
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.

United States3 registration records, 7 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: RECENSMEDICAL INC.

Company information

Country
Korea, Republic
City
Hwaseong-Si Gyeonggi

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

12021 · K203481
22022 · K221234
12023 · K230599
12024 · DEN230011
22025 · K253114

FDA listed device types

Vapocoolant Device 1QZQ 1Unit, Cryosurgical, Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253114TargetCool™ (RM-DT02W)2025-10-16
USK253348TargetCool-e2025-10-15
USDEN230011OcuCool2024-09-30
BR80686369074TargetCoolClass II

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