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Results for “Ophthalmic lenses”
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EUDAMED
1,338
FDA 510(k) incl. De Novo
4
FDA PMA
1
GUDID
1
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European Union (all)
1,338
United States
6
More countries (6)
Austria
1,308
Belgium
11
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8
France
7
Spain
2
Italy
2
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Class I
1,336
Class IIa
Class IIb
4
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Class II (US)
4
More classes (11)
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IVD General
IVD Annex II List A
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IVD for self-testing
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Verified
Verified
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Regime
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Registry
Class
Class
Nova
Vision Rx Lab Private Limited
·
,
India
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
I
UNIQA Monofocal Toric Lens, Myopic
Ziemer Ophthalmic Lenses AG
·
,
Switzerland
CE/MDR
×2
Active
Valid to Sep 2031
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIb
1.74 Aspherical Lenses
Somo Inc.
·
,
South Korea
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
I
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