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.
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（MDSAP 审核计划），有效期至 2029 年 4 月 17 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。该证书将站点地址记录为 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
- 医疗保健用品
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 在这里，中标还附带了别人做过的审查：在欧盟和欧洲经济区，公共采购方必须排除因欺诈、腐败或洗钱被定罪的投标人，以及经终局裁决认定拖欠税款或社会保险费的投标人。 这项审查只针对那次招标、截至授标之日：它不说明公司今天的状况，中标也不说明合同已经履行。 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)