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Results for “Galaxy”
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EUDAMED
300
FDA 510(k) incl. De Novo
39
FDA PMA
GUDID
1,755
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European Union (all)
203
United States
1,793
More countries (10)
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72
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43
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34
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20
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16
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15
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11
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7
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1
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1
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231
Class IIa
115
Class IIb
3
Class III
261
Class II (US)
1,361
More classes (11)
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9
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1
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IVD General
1
IVD Annex II List A
IVD Annex II List B
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Device · Manufacturer · Authorizations
Verified
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Status
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Regime
Registry
Registry
Class
Class
Orthofix Galaxy Fixation System 1
Orthofix, Inc.
·
,
FDA registration: United States
Group of variants
CE/MDD
GUDID
on market
Active
Regimes:
CE MDD
Registry:
EUDAMED
GUDID
Class
Class:
II
Orthofix Galaxy Wrist 1
Orthofix, Inc.
·
,
FDA registration: United States
CE/MDD
GUDID
on market
Active
Regimes:
CE MDD
Registry:
EUDAMED
GUDID
Class
Class:
II
Galaxy UNYCO System 1
Orthofix, Inc.
·
,
FDA registration: United States
CE/MDD
GUDID
on market
Active
Regimes:
CE MDD
Registry:
EUDAMED
GUDID
Class
Class:
II
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