Radiometer Medical ApS
Radiometer is a Danish medical device company manufacturing blood gas analysers, transcutaneous m…
Radiometer is a Danish medical device company manufacturing blood gas analysers, transcutaneous monitors, and point-of-care diagnostics used in intensive care units, emergency departments, and neonatal wards worldwide. Its ABL family of arterial blood gas analysers measures oxygen, carbon dioxide, pH, electrolytes, and metabolites on 100 µL of whole blood. Radiometer is part of Danaher Corporation and supplies hospital distributors in 130+ countries.
- Type
- brand seeking distribution
- Location
- Copenhagen, Denmark
- Founded
- 1935
- Website
- radiometer.com
- Categories
- Medical & Healthcare Supplies
- Markets
- United States, Germany, Japan, United Kingdom, France, Australia, China
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- web-presence-since (green), checked 2026-08-04 Internet Archive (Wayback)
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- public-contract-awarded (green), checked 2026-08-03 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)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
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)