Revvity
진단, 생명과학 시약 및 분석 기기.
Revvity는 Waltham 사업장에서 진단, 생명과학 시약 및 분석 장비를 제조합니다. 이 회사는 나열된 주요 시장 전반에 걸쳐 의료 시스템, 실험실, OEM 파트너 또는 규제 수출 고객에게 제품을 공급합니다.
- Type
- Manufacturer
- Location
- Waltham, United States
- Founded
- 1937
- Website
- revvity.com
- Categories
- 의료 및 건강 관리 용품, 산업기계
- Markets
- 미국, 독일, 일본, 싱가포르
Verified facts
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- fda-registered (green), checked 2026-08-12 FDA
- domain-registered (green), checked 2026-08-14 Domain registry record
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- 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)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission