Medbone-Medical Devices Lda
Tesis Brezilya sağlık düzenleme kurumu (ANVISA) tarafından onaylanmıştır
Brezilya sağlık düzenleme kurumu ANVISA, bu tesis için tıbbi cihazları kapsayan ve 2027-11-27 tarihine kadar geçerli olan geçerli bir İyi Üretim Uygulamaları sertifikasına sahiptir. Sertifika, tesisin kendi incelemesinden sonra veriliyor, bu nedenle yabancı bir düzenleyici bu siteyi adlandırıyor: Burada üretilen malların Brezilya pazarında bulunmasına izin veriliyor. İşlem numarası 25351043178201912.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Portugal
- Categories
- Tıbbi ve Sağlık Malzemeleri
- Markets
- Portekiz, Brezilya
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)