Ambu A/S
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Ambu A/S is a medical device manufacturer, with 1,307 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I) as of 12 Nov 2026.
- Devices
- 1,307
Registry facts
- Registries
- FDA GUDID 1,269
- EUDAMED 226
- FDA 510(k) 38
- Device classes
- FDA Class II 1,173
- FDA Class I 134
- Identifiers
- DUNS 305682023
What Ambu A/S makes
Ambu A/S manufactures single-use pulmonary resuscitators for neonatal and adult resuscitation, including manual devices like the SPUR® II series. Their portfolio also includes laryngeal mask airways, anaesthesia face masks, and cardiopulmonary resuscitation kits for emergency use. Additionally, they produce elastomeric infusion pumps, polysomnographs for sleep monitoring, and reusable/non-scalp cutaneous electrodes for electrocardiographic and analytical applications.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The products are intended for use in the US, adhering to applicable regulatory requirements for medical devices.
Catalogue
Search and filter all 1,307 devicesShowing 1-50 of 1,307
Company details
- DUNS number
- 305682023
- Phone
- +14107686464
Frequently asked questions
How many devices does Ambu A/S have in the registry?
The registry currently lists 1307 devices for Ambu A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ambu A/S's devices?
Among its 50 most recently registered devices, Ambu A/S has devices listed in EUDAMED (8 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ambu A/S's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ambu A/S's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ambu A/S in the registry?
The most recently registered devices listed for Ambu A/S include Ambu® aScope™ Gastro Large 582101000, aScope™ Gastro 483001000US, Ambu® SureSight® Mobile Mini Kit 390481000 and Ambu® SureSight® Mobile Kit 390471000.