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Thermo Electron Corporation

USA · Pittsburg
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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 2Class II 1Class III 0
plus 3 registration records and 14 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
17registered devices
Class I 13Class 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
0active device licences
TWTaiwanTFDA
0valid device licences
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 States3 registration records, 14 510(k), 0 PMA, 10 excluded
Brazil17 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: THERMO ELECTRON LED GmbH · THERMO ELECTRON LED GmbH · THERMO ELECTRON LED GMBH ZWEIGNIEDERLASSUNG OSTERODE · THERMO ELECTRON LED GMBH · THERMO ELECTRON CORPORATION · Thermo Electron Led Gmbh
Same-named companies — This database also contains companies with near-identical names: THERMO ELECTRON LED GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Pittsburg

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
22005
12006
102007 · K063145

FDA listed device types

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Centrifuge, Blood-Bank For In Vitro Diagnostic Use 1Accessory, Assisted Reproduction 1

Registration details (sample)

MarketIdentifierNameClass / date
USK063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS2007-10-17
USK063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL2007-10-09
USK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS2007-10-05
BR80254180486Família de Centrífugas Ventiladas Séries X e SClass I
BR80254180487Família de Centrífugas Refrigeradas Séries X e SClass I
BR80254180488Família de Centrífugas Refrigeradas Série CClass I

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