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EUDAMED
~1,771
FDA 510(k)
~18
FDA PMA
GUDID
~296
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European Union (all)
~1,602
United States
~314
More countries (18)
Austria
~822
Italy
~219
Bulgaria
~89
Netherlands
~67
Belgium
~58
Poland
~49
Croatia
~42
Germany
~38
Cyprus
~23
Türkiye
~22
France
~21
Hungary
~20
Portugal
~20
Romania
~19
Czechia
~17
Ireland
~16
Spain
~12
Greece
~11
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Class I
~1,775
Class IIa
~5
Class IIb
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Class II (US)
~220
More classes (11)
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IVD General
IVD Annex II List A
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Class
Class
Electrical Hospital Bed
Paramount Bed Co., Ltd.
·
,
Japan
CE/MDR
GUDID
not intended for market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
I
Electric Five Function Hospital Bed
Guangdong Kangshen Medical Technology Co., Ltd
·
,
China
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIa
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