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Results for “AS-100”
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EUDAMED
~1,606
FDA 510(k)
~39
FDA PMA
GUDID
~539
Country / market
European Union (all)
~1,444
United States
~578
More countries (18)
Austria
~795
Germany
~442
Türkiye
~89
France
~48
Ireland
~34
Netherlands
~28
Italy
~27
Spain
~17
Poland
~12
Northern Ireland
~9
Hungary
~8
Sweden
~8
Bulgaria
~5
Romania
~5
Belgium
~4
Portugal
~4
Czechia
~3
Luxembourg
~3
Risk class
Class I
~541
Class IIa
~114
Class IIb
~40
Class III
~258
Class II (US)
~225
More classes (11)
Class A
~1
Class B
~215
Class C
~142
Class D
IVD General
~454
IVD Annex II List A
IVD Annex II List B
~5
IVD for self-testing
Active implantable (AIMDD)
Unclassified (FDA)
~3
Not classified (FDA)
Verified
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Category (EMDN)
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196 devices found
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Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
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Regime
Registry
Registry
Class
Class
Idol
İdol Hastane Ürün. San. Ve Ti̇c. A.Ş.
·
,
Türkiye
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Aspeed 3.0
3A HEALTH CARE S.r.l.
·
,
Italy
CE/MDD
Active
Regimes:
CE MDD
Registry:
EUDAMED
Class
Class:
IIa
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