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Results for “GT20”
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EUDAMED
33
FDA 510(k) incl. De Novo
FDA PMA
GUDID
2
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European Union (all)
33
United States
2
More countries (4)
Denmark
16
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8
Czechia
6
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3
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8
Class IIa
19
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More classes (11)
Class A
7
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IVD General
1
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
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44 devices found
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Verified
Verified
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Regime
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Registry
Class
Class
STARGEL10 Neutral
Haemokinesis Ltd
·
,
Australia
CE/IVDR
Active
Regimes:
CE IVDR
Registry:
EUDAMED
Class
Class:
A
Endoscopic Gastrostomy (PEG) KIT
Beijing ZKSK Technology Co., Ltd
·
,
China
CE/MDD
Active
Regimes:
CE MDD
Registry:
EUDAMED
Class
Class:
IIb
Gastrostomy Tube and Accessories
Hangzhou Fushan Medical Appliances Co., Ltd.
·
,
China
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIb
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