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Registry EUDAMED ~923 FDA 510(k) FDA PMA GUDID ~1,519

Country / market European Union (all) ~843 United States ~1,519

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Denmark ~367 Italy ~151 Greece ~149 Germany ~48 Netherlands ~44 Ireland ~27 France ~18 Slovenia ~12 Belgium ~9 Spain ~9 Poland ~3 Romania ~3 Türkiye ~3 Hungary ~2 Croatia ~1 Liechtenstein ~1

Risk class Class I ~711 Class IIa ~538 Class IIb ~15 Class III ~15 Class II (US) ~672

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Sonic UDI-DI 05714464027743

Sbo Hearing A/S,Denmark Class IIa

Active CE MDR EUDAMEDGUDID IIa
335 variants
- Sonic 222303
- Sonic 228404
- Sonic 230652
- Sonic 236315
- Sonic 238467
- Sonic 245409
- Sonic 247782
- Sonic 248372
- Sonic 248373
- Sonic 250581
- Sonic 250721
- Sonic 250906
- Sonic 256400
- Sonic 256402
- Sonic 256416
- Sonic 257407
- See all variants of this device
Aurelia Sonic UDI-DI 09555002105570

Maxter Glove Manufacturing Sdn Bhd,Malaysia Class I

Active CE MDR EUDAMEDGUDID I
5 variants
- See all variants of this device

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