HomeKorea, RepublicCERAGEM CO., LTD.

CERAGEM CO., LTD.

Korea, Republic · Chungcheongnam-Do
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Russia — 4 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
5listed device types
Class I 2Class II 3Class III 0
plus 9 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
2active device licences
Class II 2
8 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 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.

United States9 registration records, 7 510(k), 0 PMA, 3 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: CERAGEM CO., LTD.

Company information

Country
Korea, Republic
City
Chungcheongnam-Do

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

12004 · K040031
22021 · K202937
12022 · K220572
12024 · K243355
22025 · K250266

FDA listed device types

Table, Physical Therapy, Multi Function 1Pad, Heating, Powered 1Massager, Powered Inflatable Tube 1Vibrator, Therapeutic 1Massager, Therapeutic, Electric 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250266Ceragem Automatic Thermal Massager (CGM MB-2401)2025-07-11
USK243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)2025-01-08
USK243355Ceragem Automatic Thermal Massager (CGM-MB-1902)2024-11-27
CA61814CERAGEM-CClass II
CA74225CERAGEM RHClass II

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