HemoCue
Point-of-care diagnostic systems for blood and urine testing.
HemoCue manufactures point-of-care diagnostic systems for blood and urine testing from its Angelholm operations. The company supplies hospital buyers, clinical distributors, healthcare systems or export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Angelholm, Sweden
- Founded
- 1982
- Website
- hemocue.com
- Categories
- Medical & Healthcare Supplies, Industrial Supplies
- Markets
- Sweden, United States, Germany, Japan
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- lei-lapsed (amber), checked 2026-08-08 GLEIF
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- fda-registered (green), checked 2026-08-08 FDA
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- 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)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
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)