Ambu
Dispositivos médicos, suprimentos de saúde e produtos clínicos.
Ambu fabrica dispositivos médicos, suprimentos de saúde e produtos clínicos de suas operações Ballerup. 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
- Ballerup, Denmark
- Founded
- 1937
- Website
- ambu.com
- Categories
- Suprimentos médicos e de saúde, Suprimentos industriais
- Markets
- Dinamarca, Estados Unidos, Alemanha, Japão
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
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- domain-registered (green), checked 2026-08-02 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)