Phadia AB
Active in EUDAMEDSwedenfrom SRN EUDAMED FDA SRN SE-MF-000014170 FEI 3039353646
Phadia AB is a medical device manufacturer based in Sweden, with 1,096 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class B and A; FDA Class I and II) as of 14 Nov 2026.
- Devices
- 1,096
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 801
- FDA GUDID 769
- FDA 510(k) 25
- Device classes
- EU Class B 743
- FDA Class I 207
- FDA Class II 93
- EU Class A 48
- EU Class C 3
- FDA Unclassified 2
- Top EMDN categories
- Reagents 782
- IVD instruments 12
- Identifiers
- EUDAMED SRN SE-MF-000014170
- FDA FEI 3039353646
- DUNS 354019424
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Phadia AB makes
Phadia AB manufactures in vitro diagnostic (IVD) reagents for measuring allergen-specific immunoglobulin E (IgE) antibodies and human immunoglobulin G (IgG) conjugates. Their products include allergen-specific test reagents for identifying sensitivities to substances like pollen, fungi, foods, and chemicals, as well as calibrators and controls for total IgE levels. Examples include allergen-specific tests for grass pollen, mushrooms, hazelnuts, and formaldehyde, alongside IgE calibrators and curve controls for laboratory use.
The company’s IVD reagents are classified under EU and FDA regulatory frameworks, with devices falling into Class A, B, C, and Class II categories. Their products are listed in the EU’s eudamed registry and the FDA’s 510(k) database. Phadia AB is headquartered in Sweden.
Catalogue
Search and filter all 1,096 devicesShowing 1-50 of 1,096
Company details
- EUDAMED SRN
- SE-MF-000014170
- FDA FEI number
- 3039353646
- DUNS number
- 354019424
- EU VAT number
- SE556041320401
- EUDAMED status
- Active
- EUDAMED registered name
- Phadia AB
- Registered address
- 7P, Rapsgatan, 75137, Uppsala, Sweden
- Website
- www.thermofisher.com
- Phone
- +46 18 165000
- PRRC contact
- Fredrik Mirenborn
FDA establishments
- Phadia GmbH FREIBURG Baden-Wurttemberg · DE FEI 3005774014
- Phadia GmbH US
Frequently asked questions
How many devices does Phadia AB have in the registry?
The registry currently lists 1096 devices for Phadia AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Phadia AB's devices?
Among its 50 most recently registered devices, Phadia AB has devices listed in EUDAMED (4 devices), FDA 510(k) (2 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Phadia AB's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Phadia AB's devices are Class I, Class II and IVDR Class B. Each device page shows its own class and authorisation.
What are the newest devices from Phadia AB in the registry?
The most recently registered devices listed for Phadia AB include EliA CTD 13 Screen Well DECC066610, EliA Stool Extraction Buffer plus 83-1187-01, EliA Stool Extraction Kit plus 14-6665-01 and EliA Celikey IgA Well DECC066170.
Which FDA establishments are linked to Phadia AB?
2 FDA establishments are linked to Phadia AB in the registry; they are listed on the company page.