Agilent Technologies Denmark Aps
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 (MDSAP audit programme), valid until 2029-04-17. 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 PRODUKTIONSVEJ 42 - GLOSTRUP, DK2600. Process number 25351885437201656.
- Type
- brand seeking distribution
- Location
- Glostrup, Denmark
- Categories
- Medical & Healthcare Supplies
- Markets
- Denmark, Brazil
Listed in a source registry
Verified facts
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- public-contract-awarded (green), checked 2026-08-21 TED, EU public procurement bulletin Here the award carries someone else's check: in the EU and the EEA a public buyer must exclude bidders convicted of fraud, corruption or money laundering, and those found by a final decision to owe taxes or social contributions. Directive 2014/24/EU, Article 57 (exclusion grounds)
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- facility-registered (green), checked 2026-08-30 European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- sanctions-clear (green), checked 2026-08-31 OpenSanctions
- listed-in-registry (green), checked 2026-08-31 BRIS, EU business registers interconnection (e-justice.europa.eu)
- debarment-clear (green), checked 2026-08-31 OpenSanctions
- fda-registered (green), checked 2026-08-31 FDA
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)