HomeUSACRYOCONCEPTS, LP

CRYOCONCEPTS, LP

USA · Easton
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong — 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
1listed device types
Class I 0Class II 1Class III 0
plus 16 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
1active device licences
Class II 1
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
6active ARTG entries
IIa 6
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
pendingnot queried
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 States16 registration records, 8 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: CRYOCONCEPTS LP · CRYOCONCEPTS, LP

Company information

Country
USA
City
Easton

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

12017 · K172769
22019 · K190407
12022 · K211099
22024 · K242625
22025 · K251493

FDA listed device types

Unit, Cryosurgical, Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251493Skin Clinic Freeze Point for Warts and Skin Tags2025-05-22
USK242932Skin Clinic Nitro Clear Wart Remover2025-04-15
USK242625Freeze Point & Private Label Versions2024-10-25
BR80102519181CryoClear™Class II
BR80102519187Histofreezer® STATClass II
BR80585180001POINTTSClass II
CA88039CRYOMEGAClass II

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