Ambu
الأجهزة الطبية ومستلزمات الرعاية الصحية والمنتجات السريرية.
تقوم شركة Ambu بتصنيع الأجهزة الطبية ومستلزمات الرعاية الصحية والمنتجات السريرية من عمليات Ballerup التابعة لها. تقوم الشركة بتزويد مشتري المستشفيات أو الموزعين السريريين أو أنظمة الرعاية الصحية أو عملاء التصدير عبر أسواقها الرئيسية المدرجة.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Ballerup, Denmark
- Founded
- 1937
- Website
- ambu.com
- Categories
- اللوازم الطبية والرعاية الصحية, اللوازم الصناعية
- Markets
- الدانمرك, الولايات المتحدة, ألمانيا, اليابان
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)