Medbone-Medical Devices Lda
ブラジル保健規制当局（ANVISA）の認証を受けた工場
ブラジルの保健規制当局である ANVISA は、医療機器を対象としたこの工場の有効な製造基準証明書を 2027 年 11 月 27 日まで有効に保持しています。証明書は工場自体の検査後に発行されるため、外国の規制当局がこのサイトを名前に挙げています。ここで製造された商品はブラジル市場での販売が許可されています。プロセス番号 25351043178201912。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Portugal
- Categories
- 医療およびヘルスケア用品
- Markets
- ポルトガル, ブラジル
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)