Magle Chemoswed AB
Sweden SE-MF-000003569 Last updated 21 Oct 2026
- Devices
- 2
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
SmartPAN Ref 96 07 45
Embocept S DSM 50 um Ref 493094
About
The challenges taking a product past the preclinical phase are as many as they are complex. At Magle Chemoswed we have a world-class team of specialists experienced in delivering the best possible results regarding efficacy, safety, and regulatory compliance.
What Magle Chemoswed AB makes
Magle Chemoswed AB manufactures medical devices including the SmartPAN system and the Embocept S DSM 50 µm embolic device. These products are designed for specific clinical applications, with SmartPAN serving as a specialized surgical tool and Embocept S DSM 50 µm providing a controlled embolization solution.
The company's device portfolio falls under the European Union's Class IIa and Class IIb classifications and is recorded in the Eudamed database. Magle Chemoswed AB is headquartered in Sweden.
Frequently asked questions
What medical devices does Magle Chemoswed AB manufacture?
Magle Chemoswed AB manufactures medical devices such as the SmartPAN system and the Embocept S DSM 50 µm embolic device. These products are designed for specific clinical applications, with SmartPAN serving as a specialized surgical tool and Embocept S DSM 50 µm providing a controlled embolization solution. The company’s portfolio includes these two example devices as stated in the provided data.
Where is Magle Chemoswed AB based?
Magle Chemoswed AB is headquartered in Sweden, as indicated by the country code SE in the device data. The company’s location is explicitly stated in the summary section, confirming its base of operations is in Sweden.
Which regulatory registry lists the devices of Magle Chemoswed AB?
The devices manufactured by Magle Chemoswed AB are listed in the Eudamed database, which is the European Union’s medical device registry. This is explicitly stated in both the DEVICE_DATA section under 'LISTED IN' and in the summary, confirming Eudamed as the registry where the company’s devices are recorded.
How are the devices of Magle Chemoswed AB classified under EU regulations?
The devices manufactured by Magle Chemoswed AB are classified as Class IIa and Class IIb under the European Union’s medical device classification system. This classification is directly stated in the DEVICE_DATA section and reiterated in the summary, indicating the risk-based regulatory category for their products.
Information
- Country
- Sweden
- Address
- 27, Agneslundsvägen , Malmö, Sweden
- Website
- maglechemoswed.com/
- [email protected]
- Phone
- +46 40 38 33 00
- PRRC contact
- azadeh mehdipoor
- EUDAMED SRN
- SE-MF-000003569