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Results for “SIRIO”
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EUDAMED
~40
FDA 510(k)
FDA PMA
GUDID
~1,971
Country / market
European Union (all)
~26
United States
~1,971
More countries (4)
Italy
~20
Lithuania
~4
Germany
~1
Malta
~1
Risk class
Class I
~34
Class IIa
~19
Class IIb
~3
Class III
Class II (US)
~1,944
More classes (11)
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)
Verified
Validated only
Category (EMDN)
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1,000+ devices found
·
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
Sirion GB225007B
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GB204514B
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZB12AF06
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZC11E14B
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GA244010A
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GA206018A
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZC01C16B
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GB226008B
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GB224507B
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZA07F095
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GA205516A
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GA204008A
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZA07A130
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZC10D20B
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Siemens HA SIRION 2 P GR- DGT
WS Audiology USA, Inc.
·
,
FDA registration: United States
Class I
GUDID
not on market
Withdrawn
GUDID
I
Sirion GA264020D
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZC10E06E
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GB186018B
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZC11D16C
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Sirion GZC10A06G
Astura Medical
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
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