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Results for “BASIS”
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EUDAMED
1,858
FDA 510(k) incl. De Novo
11
FDA PMA
GUDID
192
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European Union (all)
1,533
United States
203
More countries (10)
Germany
1,466
Netherlands
52
Denmark
6
Italy
3
Liechtenstein
3
France
2
Austria
1
Belgium
1
Hungary
1
Lithuania
1
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Class I
193
Class IIa
1,541
Class IIb
39
Class III
85
Class II (US)
128
More classes (11)
Class A
3
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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Verified
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Basis
Yamahachi Dental Mfg., Co.
·
,
Japan
Group of variants
CE/MDD
GUDID
on market
Active
Regimes:
CE MDD
Registry:
EUDAMED
GUDID
Class
Class:
IIa
Breast Basis Set
NORAS MRI products GmbH
·
,
Germany
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIa
Basis Flow Ii
Yamahachi Dental Mfg., Co.
·
,
Japan
CE/MDD
GUDID
on market
Active
Regimes:
CE MDD
Registry:
EUDAMED
GUDID
Class
Class:
IIa
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