AMYLASE - ANVISA Registration 81327670038
Access comprehensive regulatory information for AMYLASE in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 81327670038 and manufactured by ARKRAY FACTORY, INC.. The registration is held by DNEDX COMERCIO E SERVICOS PARA PRODUTOS DA SAUDE LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including SIEMENS HEALTHCARE DIAGNOSTICS INC., QUIBASA QUĂMICA BĂSICA LTDA, and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
81327670038
25351990088201619
22940751000120
Company Information
Dates and Status
Oct 24, 2016
VIGENTE
09/18/2025 19:00:01
AMYLASE
REATIVO SECO VITROS* PARA AMILASE AMYL
ORTHO CLINICAL DIAGNOSTICS, INC.
81246986784
Aug 28, 2017
AMYLASE
Alfa Amilase PancreĂĄtica (Reagente A+B)
BIOSYSTEMS S.A.
80367750132
Jun 09, 2022
AMYLASE
Amilase ColorimĂŠtrica
Vida Biotecnologia Ltda - ME
80785070017
Jun 18, 2012
AMYLASE
Atellica CH Amilase PancreĂĄtica (PAmy)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162161
Dec 26, 2017
AMYLASE
Atellica CH Amilase (Amylas)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162108
Nov 06, 2017
SIEMENS HEALTHCARE DIAGNOSTICS INC.⢠United States of America
QUIBASA QUĂMICA BĂSICA LTDA⢠Brazil
ROCHE DIAGNOSTICS GMBH⢠Germany
ROCHE DIAGNOSTICS⢠Germany
KATAL BIOTECNOLOGICA INDĂSTRIA E COMĂRCIO LTDA⢠Brazil
AMILASE
FamĂlia Amilase PancreĂĄtica
KATAL BIOTECNOLOGICA INDĂSTRIA E COMĂRCIO LTDA
10377390304
May 05, 2025
AMILASE
Amilase Automação - Linha DT
DAILYTECH LATINO AMERICA LTDA
80657030075
Apr 07, 2025
AMILASE
FAMĂLIA AMILASE
KATAL BIOTECNOLOGICA INDĂSTRIA E COMĂRCIO LTDA
10377390280
Feb 17, 2025
AMILASE
AMYLASE SL
DAILYTECH LATINO AMERICA LTDA
80657030036
Dec 23, 2024
AMILASE
KIT ALFA - AMILASE
MEDMAX COMĂRCIO DE EQUIPAMENTOS MĂDICOS E SIMILARES LTDA ME
81313770052
Jul 08, 2024