Aer Beatha AB
Sweden SE-MF-000041035 Last updated 21 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Aer8 Ref REF-TEST
About
Spacers helps to reduce the problems of dose inhalers as they remove the need to coordinate inhaler activation with drug inhalation. Spacers, even for smaller volume, are bulky, not particularly portable and need to be cleaned, making patients usually not using them. Most are made of hard plastic, are not foldable or recyclable and must be incinerated in waste management. The Aer8-Spacer has a large volume but is easy to carry as it can be folded between the uses. It is plastic-free, biodegradable and environmentally friendly.
What Aer Beatha AB makes
Aer Beatha AB manufactures the Aer8, a foldable spacer designed to improve the administration of inhaled medications by eliminating the need for patient coordination between inhaler activation and drug inhalation. The device is constructed without plastic, is biodegradable, and is intended to be more portable and environmentally friendly than traditional spacers.
The Aer8 is classified as a Class I medical device and is listed in the EU’s eudamed registry. The company is based in Sweden.
Frequently asked questions
What types of medical devices does Aer Beatha AB manufacture?
Aer Beatha AB specializes in spacers, specifically the Aer8. This device is designed to help patients administer inhaled medications more effectively by eliminating the need to coordinate inhaler activation with breathing. The Aer8 is particularly notable for its foldable, plastic-free, and biodegradable construction, addressing common issues like portability and environmental impact associated with traditional spacers.
Where is Aer Beatha AB based?
Aer Beatha AB is based in Sweden (SE). The company’s location in Sweden may influence its regulatory compliance and market focus, particularly within the European Union.
Are Aer Beatha AB’s devices listed in any regulatory registries?
Yes, Aer Beatha AB’s devices are listed in the EU’s eudamed registry. This database is used to track medical devices authorized for placement on the European market, ensuring transparency and traceability for regulatory oversight.
How are Aer Beatha AB’s devices classified under medical device regulations?
The Aer8 spacer manufactured by Aer Beatha AB is classified as a Class I medical device. This classification is typically assigned to devices posing minimal risk to patients, such as simple accessories like spacers, which do not require invasive procedures or sustained use. Classification determines regulatory requirements, with Class I devices generally subject to fewer stringent controls than higher-risk categories.
Information
- Country
- Sweden
- Address
- 36, Hultgrens Vag, Lerum, Sweden
- Website
- www.aerbeatha.com/
- [email protected]
- Phone
- +46701757298
- PRRC contact
- Michael Friel
- EUDAMED SRN
- SE-MF-000041035