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EUDAMED
759
FDA 510(k) incl. De Novo
102
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542
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652
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644
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229
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107
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89
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390
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316
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251
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3
IVD Annex II List A
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IVD for self-testing
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Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
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Regime
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Registry
Class
Class
Obey I
US Orthodontic Products
·
,
United States
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Mini SBT Roth 022 UL7
US Orthodontic Products
·
,
United States
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
SBT Roth 018 - DB UL7 (NICKEL LITE)
US Orthodontic Products
·
,
United States
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
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