IDEXX Laboratories
수의학 진단, 분석기 및 동물 건강 테스트 제품.
IDEXX Laboratories는 Westbrook 사업장에서 수의학 진단기, 분석기, 동물 건강 테스트 제품을 제조합니다. 이 회사는 나열된 주요 시장 전반에 걸쳐 의료 시스템, 실험실, OEM 파트너 또는 규제 수출 고객에게 제품을 공급합니다.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Westbrook, United States
- Founded
- 1983
- Website
- idexx.com
- Categories
- 의료 및 건강 관리 용품, 애완동물 관리 및 액세서리
- Markets
- 미국, 독일, 일본, 오스트레일리아
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
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
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- facility-registered (green), effective since 2026-08-07 US EPA Facility Registry Service (national combined file)
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- industrial-permit (green), checked 2026-08-23 ECHO, Enforcement and Compliance History Online (U.S. Environmental Protection Agency)
- registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record
Claimed certifications, not confirmed by us
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
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)
- Consumer goods sold in the EU fall under the General Product Safety Regulation (GPSR, applies since 13 Dec 2024): a responsible person in the EU is mandatory. EUR-Lex: Regulation (EU) 2023/988 (GPSR)