Coloplast
Cuidados com ostomias, cuidados com a continência, cuidados com feridas e dispositivos urológicos.
A Coloplast fabrica dispositivos para cuidados com ostomia, cuidados com continência, cuidados com feridas e urologia em suas operações em Humlebaek. A empresa fornece compradores de hospitais, distribuidores clínicos, sistemas de saúde ou clientes de exportação em seus principais mercados listados.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Humlebaek, Denmark
- Founded
- 1957
- Website
- coloplast.com
- Categories
- Suprimentos médicos e de saúde, Suprimentos industriais
- Markets
- Dinamarca, Alemanha, Estados Unidos, Reino Unido
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)