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Results for “Sonic”
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EUDAMED
~923
FDA 510(k)
FDA PMA
GUDID
~1,519
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European Union (all)
~843
United States
~1,519
More countries (16)
Denmark
~367
Italy
~151
Greece
~149
Germany
~48
Netherlands
~44
Ireland
~27
France
~18
Slovenia
~12
Belgium
~9
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~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
More classes (11)
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IVD Annex II List A
IVD Annex II List B
IVD for self-testing
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Verified
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Status
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Regime
Registry
Registry
Class
Class
Sonic
Sbo Hearing A/S
·
,
Denmark
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIa
Sonicaid
Arjohuntleigh AB
·
,
Sweden
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIb
Sonicaid
Arjohuntleigh AB
·
,
Sweden
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
I
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