Coloplast
장루 관리, 실금 관리, 상처 관리 및 비뇨기과 장치.
Coloplast는 Humlebaek 사업장에서 장루 관리, 요실금 관리, 상처 치료 및 비뇨기과 기기를 제조합니다. 이 회사는 나열된 주요 시장 전반에 걸쳐 병원 구매자, 임상 유통업체, 의료 시스템 또는 수출 고객에게 제품을 공급합니다.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Humlebaek, Denmark
- Founded
- 1957
- Website
- coloplast.com
- Categories
- 의료 및 건강 관리 용품, 산업용품
- Markets
- 덴마크, 독일, 미국, 영국
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
- lei-active (green), checked 2026-08-05 GLEIF
- sanctions-clear (green), checked 2026-08-05 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- fda-registered (green), checked 2026-08-05 FDA
- debarment-clear (green), checked 2026-08-05 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-05 Mail server of the company domain
- domain-registered (green), checked 2026-08-05 Domain registry record
Claimed certifications, not confirmed by us
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)