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ANVISA registration 80885650107Valid until Dec 08, 2035

TROPONIN

ANVISA Registration Number: 80885650107ORBITAE DIAGNOSTICOS S/AASSURE TECH. (HANGZHOU) CO., LTDRisk Class III
Verified
Device names
Technical name
TROPONIN
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PT: TROPONINA
Commercial name
hs-cTnI (Troponina Ultrassensível) FIA Assure Test
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Risk class
Class III
Registration details
Registration Number
80885650107
Process Number
25351177495202571
CNPJ
11162384000165
Company information
Registration Holder
ORBITAE DIAGNOSTICOS S/A
Manufacturer
ASSURE TECH. (HANGZHOU) CO., LTD
Manufacturing Country
China
PT: CHINA, REPÚBLICA POPULAR
Dates and status
Publication Date
Dec 08, 2025
Validity
08/12/2035
Last Updated
08/18/2026 19:00:00
About this record

Access comprehensive regulatory information for TROPONIN in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80885650107 and manufactured by ASSURE TECH. (HANGZHOU) CO., LTD. The registration is held by ORBITAE DIAGNOSTICOS S/A with validity until Dec 08, 2035.

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.