Ambu
Tıbbi cihazlar, sağlık malzemeleri ve klinik ürünler.
Ambu, Ballerup operasyonlarından tıbbi cihazlar, sağlık malzemeleri ve klinik ürünler üretmektedir. Şirket, listelenen birincil pazarlardaki hastane alıcılarına, klinik distribütörlerine, sağlık sistemlerine veya ihracat müşterilerine hizmet vermektedir.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Ballerup, Denmark
- Founded
- 1937
- Website
- ambu.com
- Categories
- Tıbbi ve Sağlık Malzemeleri, Endüstriyel Malzemeler
- Markets
- Danimarka, Amerika Birleşik Devletleri, Almanya, Japonya
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)