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EUDAMED
~923
FDA 510(k)
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GUDID
~1,519
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European Union (all)
~843
United States
~1,519
More countries (16)
Denmark
~367
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~151
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~149
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~48
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~44
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~27
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~18
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~12
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~9
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~9
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~3
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~3
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~3
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~2
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~1
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~1
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~711
Class IIa
~538
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~15
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~15
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~672
More classes (11)
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IVD Annex II List A
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IVD for self-testing
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Sonic
UDI-DI 05714464055005
Sbo Hearing A/S
·
,
Denmark
Class IIa
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
IIa
335 variants
Sonic
222307
Sonic
222308
Sonic
229371
Sonic
230653
Sonic
234747
Sonic
234764
Sonic
236300
Sonic
245400
Sonic
247780
Sonic
248364
Sonic
248365
Sonic
250573
Sonic
251740
Sonic
256413
Sonic
257409
Sonic
258748
See all variants of this device
Sonicaid
UDI-DI 05051968030054
Arjohuntleigh AB
·
,
Sweden
Class IIa
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
IIa
4 variants
See all variants of this device
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