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Results for “INTRO KIT”
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EUDAMED
1,092
FDA 510(k) incl. De Novo
79
FDA PMA
GUDID
925
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European Union (all)
1,004
United States
1,004
More countries (14)
Poland
367
Belgium
286
Italy
257
Germany
36
Spain
19
Ireland
15
Malta
13
Netherlands
3
Croatia
2
Portugal
2
Austria
1
France
1
Lithuania
1
Sweden
1
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Class I
44
Class IIa
1,040
Class IIb
12
Class III
3
Class II (US)
656
More classes (11)
Class A
2
Class B
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Class D
IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
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Registry
Class
Class
Kit for stent introduction
Balton Sp. z o.o.
·
,
Poland
Group of variants
CE/MDD
Active
Regimes:
CE MDD
Registry:
EUDAMED
Class
Class:
IIa
Introducer Sheath Kits
Beijing Demax Medical Technology Co., Ltd.
·
,
China
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
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