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Home›USA›Neothermia Corporation

Neothermia Corporation

USA · Natick
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
10510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 10 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 States0 registration records, 10 510(k), 0 PMA

Company information

Country
USA
City
Natick

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

12001
42002 · K023413
12003 · K033427
22004 · K042170
22005 · K052246

Registration details (sample)

MarketIdentifierNameClass / date
USK052246MODIFICATION TO EN-BLOC BIOPSY SYSTEM2005-08-22
USK050737NEOTHERMIA EN-BLOC BIOPSY SYSTEM2005-03-31
USK042170EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-1202004-09-07

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