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Results for “Oticon”
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EUDAMED
~1,103
FDA 510(k)
~1
FDA PMA
GUDID
~1,998
Country / market
European Union (all)
~1,071
United States
~1,999
More countries (2)
Denmark
~946
Sweden
~125
Risk class
Class I
~165
Class IIa
~972
Class IIb
Class III
Class II (US)
~863
More classes (11)
Class A
Class B
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IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
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1,000+ devices found
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
Ponto 5 Mini, STG
Oticon Medical AB
·
,
Sweden
Class IIa
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
IIa
Oticon
UDI-DI 05714464041411
Sbo Hearing A/S
·
,
Denmark
Class IIa
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
IIa
931 variants
Oticon
221885
Oticon
221889
Oticon
228737
Oticon
229703
Oticon
230284
Oticon
235686
Oticon
238010
Oticon
238373
Oticon
240478
Oticon
245365
Oticon
248470
Oticon
268329
Withdrawn
Oticon
269594
Oticon
276293
See all variants of this device
Softband 5, Unilateral M/L Light Blue
Oticon Medical AB
·
,
Sweden
Class I
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
I
Soft band, Black
Oticon Medical AB
·
,
Sweden
Class I
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
I
Soft band, Pink
Oticon Medical AB
·
,
Sweden
Class I
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
I
Ponto Soft band, bilateral, navy
Oticon Medical AB
·
,
Sweden
Class I
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
I
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