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ANVISA registration 80003610553Active

PRODUCT FOR HEMOSTASIS ASSESSMENT

ANVISA Registration Number: 80003610553WERFEN MEDICAL LTDATEM INNOVATIONS GMBHRisk Class II
Verified
Device names
Technical name
PRODUCT FOR HEMOSTASIS ASSESSMENT
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PT: PRODUTO PARA AVALIAÇÃO DA HEMOSTASIA
Commercial name
ROTEM sigma complete + hep
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Risk class
Class II
Registration details
Registration Number
80003610553
Process Number
25351367619201769
CNPJ
02004662000165
Company information
Registration Holder
WERFEN MEDICAL LTDA
Manufacturer
TEM INNOVATIONS GMBH
Manufacturing Country
Germany
PT: ALEMANHA
Dates and status
Publication Date
Feb 14, 2018
Validity
VIGENTE
Last Updated
08/18/2026 19:00:00
About this record

Access comprehensive regulatory information for PRODUCT FOR HEMOSTASIS ASSESSMENT in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80003610553 and manufactured by TEM INNOVATIONS GMBH. The registration is held by WERFEN MEDICAL 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.