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WIENER LABORATÓRIO S.A.I.C.

Argentina

✓ 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

50listed device types

Class I 30Class II 20Class III 0

plus 44 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

268registered devices

Class I 36Class II 232

343 including historic records

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 States44 registration records, 1 510(k), 0 PMA, 2 excluded

Brazil268 confirmed, 1 excluded

Manufacturer names merged into this page: WIENER LABORATORIOS S.A.I.C. · WIENER LABORATÓRIOS S.A.I.C. · WIENER LABORATORIOS S.A.I.C · WIENER LABORATÓRIO S.A.I.C.

FDA 510(k) clearances by year

12009 · K083724

FDA listed device types

showing 8 of 50

2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase 1U.V. Method, Cpk Isoenzymes 1Catalytic Methods, Amylase 1Biuret (Colorimetric), Total Protein 1Blood, Occult, Colorimetric, In Urine 1Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 1Calibrator, Multi-Analyte Mixture 1Nadh Oxidation/Nad Reduction, Ast/Sgot 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K083724	WIENER LAB. URINE STRIP 10 AND 11	2009-09-02
BR	10268590110	ASO LATEX LINEA TURBITEST AA WIENER	Class II
BR	10268590107	GPT (ALT) UV AA WIENER	Class II
BR	10268590316	LDL Colesterol monofase AA	Class II

WIENER LABORATÓRIO S.A.I.C.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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