PROCALCITONIN PCT - CLASS II - ANVISA Registration 80115310263
Access comprehensive regulatory information for PROCALCITONIN PCT - CLASS II in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80115310263 and manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH. The registration is held by KOVALENT DO BRASIL 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 BODITECH MED INC., DIASORIN ITALIA S.P.A., 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
80115310263
25351802395202081
04842199000156
Company Information
Dates and Status
Sep 21, 2020
VIGENTE
09/18/2025 19:00:01
PROCALCITONIN PCT - CLASS II
FamĂlia Procalcitonin (PCT)
WIENER LABORATORIOS S.A.I.C.
10246810329
Jan 13, 2020
PROCALCITONIN PCT - CLASS II
FamĂlia SuperFlex Procalcitonin
SUZHOU SYM-BIO LIFESCIENCE CO., LTD
10298910163
Aug 05, 2021
PROCALCITONIN PCT - CLASS II
Familia BRAHMS Procalcitonina (PCT)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
10345162317
Apr 01, 2019
PROCALCITONIN PCT - CLASS II
FAMĂŤLIA ichroma PCT
BODITECH MED INC.
10350840283
Aug 15, 2016
PROCALCITONIN PCT - CLASS II
FamĂlia AFIAS PCT Plus
BODITECH MED INC.
10350840374
Aug 17, 2020
BODITECH MED INC.• South Korea
DIASORIN ITALIA S.P.A.• Italy
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.• China
SIEMENS HEALTHCARE DIAGNOSTICS INC• United States of America
PROCALCITONINA PCT - CLASSE II
Kit de Teste Rápido Procalcitonina (PCT) (Teste Imunocromatográfico por Fluorescência)
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.
82444370086
Jan 22, 2024
PROCALCITONINA PCT - CLASSE II
FASTLINE PCT
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220164
Jan 15, 2024
PROCALCITONINA PCT - CLASSE II
FamĂlia AutoLumo PCT MicropartĂculas (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513101
Oct 09, 2023
PROCALCITONINA PCT - CLASSE II
FamĂlia Dimension Procalcitonina (PCT)
SIEMENS HEALTHCARE DIAGNOSTICS INC
10345162465
May 02, 2023
PROCALCITONINA PCT - CLASSE II
Procalcitonina (Imunoensaio de EletroquimioluminescĂŞncia)
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.
80102512990
Apr 17, 2023