Biotecnologias Srl
Plant certified by the Brazilian health regulator (ANVISA)
ANVISA, the Brazilian health regulator, holds a valid Good Manufacturing Practice certificate for this plant, covering medical devices, valid until 2027-04-17. The certificate is issued after an inspection of the plant itself, which is why a foreign regulator names this site: goods made here are allowed on the Brazilian market. The certificate records the site address as AV. EVA PERON 1452, LOTE 80 (PQE INDUSTRIAL METROPOLITANO, PEREZ, SANTA FÉ, 2121. Process number 25351535452202019.
- Type
- Manufacturer
- Location
- Santa Fé, Argentina
- Categories
- 의료 및 건강 관리 용품
- Markets
- 아르헨티나, 브라질
Listed in a source registry
Verified facts
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- tax-filing-active (green), checked 2026-08-15 ARCA (Argentine tax authority), full taxpayer status file (Constancia de inscripcion, RG 1817)
- registry-id-verified (green), checked 2026-08-21 Taxpayer status file (Constancia de inscripcion)
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)