Medtronic
심혈관, 수술, 당뇨병 및 신경과학 의료 기술.
메드트로닉은 더블린 사업장에서 심혈관, 외과, 당뇨병 및 신경과학 의료 기술을 제조합니다. 이 회사는 나열된 주요 시장 전반에 걸쳐 의료 시스템, 실험실, OEM 파트너 또는 규제 수출 고객에게 제품을 공급합니다.
- Type
- Manufacturer
- Location
- Dublin, Ireland
- Founded
- 1949
- Website
- medtronic.com
- Categories
- 의료 및 건강 관리 용품, 가전제품
- Markets
- 아일랜드, 미국, 독일, 일본
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- fda-registered (green), checked 2026-08-09 FDA
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
Claimed certifications
- ISO 13485, Medical Devices Quality 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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)