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ANVISA registration 80686369150Active

Home CPAP unit

ANVISA Registration Number: 80686369150MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDALOWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG.Risk Class II
Verified
Device names
Technical name
Home CPAP unit
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PT: Unidade CPAP doméstica
Commercial name
prisma SMART plus prisma SOFT plus
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Risk class
Class II
Registration details
Registration Number
80686369150
Process Number
25351077214202662
CNPJ
09117476000181
Company information
Registration Holder
MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDA
Manufacturer
LOWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG.
Manufacturing Country
Germany
PT: ALEMANHA
Dates and status
Publication Date
May 25, 2026
Validity
VIGENTE
Last Updated
08/18/2026 19:00:00
About this record

Access comprehensive regulatory information for Home CPAP unit in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80686369150 and manufactured by LOWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG.. The registration is held by MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR 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.