Ceramed - Ceramicos Para Aplicações Médicas S.A
مصنع معتمد من هيئة تنظيم الصحة البرازيلية (ANVISA)
ANVISA، هيئة تنظيم الصحة البرازيلية، حاصلة على شهادة ممارسات التصنيع الجيدة لهذا المصنع، والتي تغطي الأجهزة الطبية، صالحة حتى 2026-10-07. يتم إصدار الشهادة بعد فحص المصنع نفسه، ولهذا السبب قامت هيئة تنظيمية أجنبية بتسمية هذا الموقع: البضائع المصنوعة هنا مسموح بها في السوق البرازيلية. تسجل الشهادة عنوان الموقع باسم RUA JOSÉ GOMES FERREIRA, N. ° 1, ARMAZÉM D, SíO JULIão DO TOJAL, LOURES 2660-360. رقم العملية 25351426377201954.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Lisboa, Portugal
- Categories
- اللوازم الطبية والرعاية الصحية
- Markets
- البرتغال, البرازيل
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
- 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
- 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
- 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)