Agilent Technologies Denmark Aps
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
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
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Glostrup, Denmark
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 6 official records from 6 official sources are on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Site address listed in a government regulator's register (record type: facility-registered) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-10-15. European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the establishment is approved for the listed activities under the EU food-hygiene rules and appears in the EU list of approved establishments. It is not an import check and not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
- manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-17. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-31. OpenSanctions
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-31. OpenSanctions
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-31. FDA
- Listed in a source registry (record type: listed-in-registry) [official record; status amber] Listed in Erhvervsstyrelsen; entry number 21852902. Matched to this company by name only; no second anchor confirms it is the same legal entity.. Found in a named public register, not only on its own website. checked 2026-08-31. BRIS, EU business registers interconnection (e-justice.europa.eu)
- Takes part in public tenders (record type: public-contract-awarded) [official record; status green] A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2026-09-08. 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. That check applied to this tender on the date of the award: it does not show the company's situation today, and winning a contract does not show that it was carried out. Directive 2014/24/EU, Article 57 (exclusion grounds)
Relationships
3 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Candidates, not confirmed
- Agilent Technologies Denmark ApS: Site named in the record. European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- Produktionsvej 42, 2600, Glostrup: Holds the site's permit, registry number DK-3-tek-966948. TRACES NT, European Commission register of approved establishments (DG SANTE)
- PRODUKTIONSVEJ 42 - GLOSTRUP, DK2600: Manufactures at the site. 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)