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Sign in to claim this brandAbilia AB
Sweden·SE-MF-000005211
Last updated May 30, 2026
What Abilia AB makes
Abilia AB manufactures voice synthesizer and digitizer devices, including communication aids like the Lightwriter and the 46289 model. These products are designed to assist individuals with speech impairments by converting text to speech or digitizing spoken language for alternative communication.
The company’s portfolio includes devices classified as Class I and Class II under regulatory frameworks. Their products are listed in the EU’s EUDAMED database and the FDA’s UDI system, reflecting compliance with European and U.S. medical device regulations. The company is based in Sweden.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Abilia AB manufacture?
Abilia AB manufactures voice synthesizer and digitizer devices, including communication aids like the Lightwriter and the 46289 model, which assist individuals with speech impairments by converting text to speech or digitizing spoken language.
Where is Abilia AB based?
Abilia AB is based in Sweden, as indicated by the country code SE in their device registration information.
Which regulatory registries list Abilia AB's devices?
Abilia AB's devices are listed in the EU's EUDAMED database and the FDA's UDI system, demonstrating compliance with both European and U.S. medical device regulations.
How are Abilia AB's devices classified?
Abilia AB's devices are classified as Class I and Class II under regulatory frameworks, with Class I being lower risk and Class II requiring more stringent controls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Sweden
- Address
- 6, Råsundavägen, SOLNA, Sweden
- Website
- www.abilia.se
- —
- —
- [email protected]
- Phone
- +46 8 594 694 00
- PRRC Contact
- Peter Löwendahl
- EUDAMED SRN
- SE-MF-000005211
- FDA FEI Number
- —
- DUNS Number
- 354656621
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lightwriter | SL50 | FDA UDI | Class II | Active |
| 46289 | 46289 | EUDAMED | Class I | Active |
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