Ceramed - Ceramicos Para Aplicações Médicas S.A
工厂获得巴西卫生监管机构（ANVISA）认证
巴西卫生监管机构 ANVISA 持有该工厂有效的良好生产规范证书，涵盖医疗器械，有效期至 2026 年 10 月 7 日。该证书是在对工厂本身进行检查后颁发的，这就是外国监管机构命名该工厂的原因：这里生产的产品可以进入巴西市场。该证书记录的站点地址为 RUA JOSÉ GOMES FERREIRA, N. º 1, ARMAZÉM D, SãO JULIãO DO TOJAL, LOURES 2660-360。进程号25351426377201954。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Lisboa, Portugal
- Categories
- 医疗保健用品
- Markets
- 葡萄牙, 巴西
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)