Ambu
医疗器械、保健用品和临床产品。
Ambu 通过其巴勒鲁普工厂生产医疗设备、医疗保健用品和临床产品。该公司向其上市主要市场的医院买家、临床分销商、医疗保健系统或出口客户提供服务。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Ballerup, Denmark
- Founded
- 1937
- Website
- ambu.com
- Categories
- 医疗保健用品, 工业用品
- Markets
- 丹麦, 美国, 德国, 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)