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Results for “POWER PRO”
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EUDAMED
443
FDA 510(k) incl. De Novo
115
FDA PMA
1
GUDID
870
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European Union (all)
411
United States
986
More countries (17)
Ireland
162
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87
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43
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24
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23
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22
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21
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9
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9
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9
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7
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7
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4
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2
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2
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1
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1
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Class I
343
Class IIa
146
Class IIb
28
Class III
22
Class II (US)
731
More classes (11)
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IVD Annex II List A
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IVD for self-testing
Active implantable (AIMDD)
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POWERFLEX™ PRO Percutaneous Transluminal Angioplasty (PTA) Catheter
Cordis US Corp.
·
,
United States
Group of variants
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIa
Power scooter
Heartway Medical Products Co., Ltd.
·
,
Taiwan
Group of variants
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
I
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