Medbone-Medical Devices Lda
Roślina certyfikowana przez brazylijski organ regulacyjny ds. zdrowia (ANVISA)
ANVISA, brazylijski organ regulacyjny ds. zdrowia, posiada dla tego zakładu ważny certyfikat Dobrej Praktyki Produkcyjnej, obejmujący wyroby medyczne, ważny do 27.11.2027 r. Certyfikat wydawany jest po inspekcji samego zakładu, dlatego zagraniczny organ regulacyjny nadaje tej witrynie nazwę: towary tu wyprodukowane są dopuszczone do obrotu na rynku brazylijskim. Numer procesu 25351043178201912.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Portugal
- Categories
- Artykuły medyczne i związane z opieką zdrowotną
- Markets
- Portugalia, Brazylia
Listed in a source registry
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- debarment-clear (green), checked 2026-08-24 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-08-24 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)