Ambu
医療機器、ヘルスケア用品、臨床製品。
Ambu は、Ballerup 事業から医療機器、ヘルスケア用品、臨床製品を製造しています。同社は、病院のバイヤー、臨床販売代理店、医療システム、または上場主要市場全体の輸出顧客に供給しています。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Ballerup, Denmark
- Founded
- 1937
- Website
- ambu.com
- Categories
- 医療およびヘルスケア用品, 産業用品
- Markets
- デンマーク, アメリカ合衆国, ドイツ, 日本
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)