MUTATIONS (GENIC, STRUCTURAL, NUMERICAL OR ANEUPLOIDIES) - ANVISA Registration 80117580511
Access comprehensive regulatory information for MUTATIONS (GENIC, STRUCTURAL, NUMERICAL OR ANEUPLOIDIES) in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80117580511 and manufactured by BIOCARTIS NV. The registration is held by EMERGO BRAZIL IMPORT IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS HOSPITALARES LTDA with validity until Jan 30, 2027.
This page provides complete technical specifications for 2 related devices, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including QIAGEN GMBH, DIATECH PHARMACOGENETICS S.R.L., 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80117580511
25351228113201648
04967408000198
Company Information
Dates and Status
Jan 30, 2017
30/01/2027
09/18/2025 19:00:01
MUTATIONS (GENIC, STRUCTURAL, NUMERICAL OR ANEUPLOIDIES)
Família Idylla Mutation Tests
BIOCARTIS NV
80117580727
Nov 12, 2018
MUTATIONS (GENIC, STRUCTURAL, NUMERICAL OR ANEUPLOIDIES)
Família Idylla Mutation Tests
Not specified
80117580727
Nov 12, 2018
MUTATIONS (GENIC, STRUCTURAL, NUMERICAL OR ANEUPLOIDIES)
Família Idylla EGFR Mutation Test
BIOCARTIS N.V.
80117580651
Feb 19, 2018
MUTATIONS (GENIC, STRUCTURAL, NUMERICAL OR ANEUPLOIDIES)
Família Idylla EGFR Mutation Test
Not specified
80117580651
Feb 19, 2018
MUTATIONS (GENIC, STRUCTURAL, NUMERICAL OR ANEUPLOIDIES)
Idylla KRAS Mutation Test
Not specified
80117580661
Mar 12, 2018
MUTAÇÕES (GÊNICAS, ESTRUTURAIS, NUMÉRICAS OU ANEUPLOIDIAS)
Família Sonda Controle RNA
Not specified
10337990055
Jul 21, 2025
MUTAÇÕES (GÊNICAS, ESTRUTURAIS, NUMÉRICAS OU ANEUPLOIDIAS)
Família Sonda Controle RNA
LEICA BIOSYSTEMS NEWCASTLE LTD
10337990055
Jul 21, 2025
MUTAÇÕES (GÊNICAS, ESTRUTURAIS, NUMÉRICAS OU ANEUPLOIDIAS)
Controle HER2 FISH
LEICA BIOSYSTEMS NEWCASTLE LTD
10337990056
Jul 21, 2025
MUTAÇÕES (GÊNICAS, ESTRUTURAIS, NUMÉRICAS OU ANEUPLOIDIAS)
Controle HER2 FISH
Not specified
10337990056
Jul 21, 2025
MUTAÇÕES (GÊNICAS, ESTRUTURAIS, NUMÉRICAS OU ANEUPLOIDIAS)
AZF Microdeletions REAL-TIME PCR Genotyping Kit
DNA-TECHNOLOGY, RESEARCH & PRODUCTION
82149920121
Jun 02, 2025