Coloplast
Cuidado de ostomía, cuidado de incontinencia, cuidado de heridas y dispositivos de urología.
Coloplast fabrica dispositivos para el cuidado de ostomías, incontinencia, heridas y urología en sus operaciones de Humlebaek. La empresa abastece a compradores de hospitales, distribuidores clínicos, sistemas de salud o clientes de exportación en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Humlebaek, Denmark
- Founded
- 1957
- Website
- coloplast.com
- Categories
- Suministros médicos y sanitarios, Suministros industriales
- Markets
- Dinamarca, Alemania, Estados Unidos, Reino Unido
Verified facts
- lei-active (green), checked 2026-08-05 GLEIF
- sanctions-clear (green), checked 2026-08-05 OpenSanctions
- fda-registered (green), checked 2026-08-05 FDA
- debarment-clear (green), checked 2026-08-05 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
- 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)