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ANVISA registration 10287411760Active

GLYCATED HEMOGLOBIN (HbA1C)

ANVISA Registration Number: 10287411760ROCHE DIAGNÓSTICA BRASIL LTDAROCHE DIAGNOSTICS GMBHRisk Class II
Verified
Device names
Technical name
GLYCATED HEMOGLOBIN (HbA1C)
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PT: HEMOGLOBINA GLICADA (HbA1C)
Commercial name
Tina-quant Hemoglobin A1cDx Gen.3
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Risk class
Class II
Registration details
Registration Number
10287411760
Process Number
25351126535202517
CNPJ
30280358000186
Company information
Registration Holder
ROCHE DIAGNÓSTICA BRASIL LTDA
Manufacturer
ROCHE DIAGNOSTICS GMBH
Manufacturing Country
Germany
PT: ALEMANHA
Dates and status
Publication Date
Sep 08, 2025
Status
Active
Official value: VIGENTE
About this record

Access comprehensive regulatory information for GLYCATED HEMOGLOBIN (HbA1C) in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 10287411760 and manufactured by ROCHE DIAGNOSTICS GMBH. The registration is held by ROCHE DIAGNÓSTICA BRASIL LTDA with validity until currently active (VIGENTE).

This page shows the facts attached to this official registry row. Exact-name links return deterministic registry matches; open-ended comparison and market analysis are handed to AI Search with this record's context, without asserting that similar names represent the same entity.