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ANVISA registration 82444370345Active

Instrument intended for immunoassays

ANVISA Registration Number: 82444370345Enzytec Biotecnologia Ltda.HANGZHOU DALTON BIOSCIENCES, LTDRisk Class II
Verified
Device names
Technical name
Instrument intended for immunoassays
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PT: Instrumento destinado a imunoensaios
Commercial name
Chemiluminescence Immunoassay Analyzer CS-SA301C
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Risk class
Class II
Registration details
Registration Number
82444370345
Process Number
25351032763202616
CNPJ
07214566000165
Company information
Registration Holder
Enzytec Biotecnologia Ltda.
Manufacturer
HANGZHOU DALTON BIOSCIENCES, LTD
Manufacturing Country
China
PT: CHINA, REPÚBLICA POPULAR
Dates and status
Publication Date
Apr 13, 2026
Status
Active
Official value: VIGENTE
Last Updated
08/18/2026 19:00:00
About this record

Access comprehensive regulatory information for Instrument intended for immunoassays in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 82444370345 and manufactured by HANGZHOU DALTON BIOSCIENCES, LTD. The registration is held by Enzytec Biotecnologia 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.