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Home›ECKERT & ZIEGLER BRASIL COMERCIAL LTDA

ECKERT & ZIEGLER BRASIL COMERCIAL LTDA

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
4listed device types
Class I 3Class II 1Class III 0
plus 4 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
14registered devices
Class I 3Class II 11
21 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
22active device licences
Class II 16Class III 6
37 including historic records
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 States4 registration records, 4 510(k), 0 PMA
Brazil14 confirmed, 0 excluded
Canada22 confirmed, 0 excluded
Manufacturer names merged into this page: ECKERT & ZIEGLER ISOTOPE PRODUCTS · ECKERT & ZIEGLER BEBIG GMBH · ECKERT & ZIEGLER BEBIG, INC. · ECKERT & ZIEGLER BRASIL COMERCIAL LTDA · Eckert & Ziegler Isotope Products
Same-named companies — This database also contains companies with near-identical names: ECKERT & ZIEGLER BEBIG, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

12013 · K123263
12014 · K140849
22015 · K141900

FDA listed device types

Phantom, Test-Pattern, Radionuclide 1Phantom, Flood Source, Nuclear 1Source, Calibration, Sealed, Nuclear 1Source, Brachytherapy, Radionuclide 1

Registration details (sample)

MarketIdentifierNameClass / date
USK141900SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE2015-05-20
USK142986SagiNova2015-04-17
USK140849ISOSEED2014-07-02
BR80012599015Fontes para Garantia da QualidadeClass II
BR80012599016Família de Fontes Lineares e Pontuais para Correção da AtenuaçãoClass II
BR80012599017Família de Fontes Marcadoras e RéguasClass II
CA68531GD-153 SOURCEClass II
CA68532C-THRU FLOOD SOURCEClass II
CA68534GAMMA COUNTER SOURCEClass II

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