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Results for “Vela”
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598
FDA 510(k) incl. De Novo
26
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217
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554
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243
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66
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IVD Annex II List A
1
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3
IVD for self-testing
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AtmosAir Velaris
Arjohuntleigh AB
·
,
Sweden
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
I
Medical Diode Laser Systems
Wuhan Gigaa Optronics Technology Co., Ltd.
·
,
China
CE/MDD
Active
Regimes:
CE MDD
Registry:
EUDAMED
Class
Class:
IIb
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