SELVAS Healthcare, Inc.

Address:155, Sinseong-ro,Yuseong-gu Daejeon,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Analyzer, Body Composition, Exempt (PUH) (4) Analyzer, Body Composition (MNW) (2) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2)

Premarket Exempt

No Yes

Clear

ACCUNIQ - 08805116000119 Catalog Number :

Device Class : 2

Duns Number: 689700711

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

ACCUNIQ - 08805116000133 Catalog Number :

Device Class : 2

Duns Number: 689700711

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

ACCUNIQ - 08805116000140 Catalog Number :

Device Class : 2

Duns Number: 689700711

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

ACCUNIQ - 08805116000157 Catalog Number :

Device Class : 2

Duns Number: 689700711

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

ACCUNIQ - 08805116000164 Catalog Number :

Device Class : 2

Duns Number: 689700711

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

ACCUNIQ - 08805116000300 Catalog Number :

Device Class : 2

Duns Number: 689700711

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

ACCUNIQ - 08805116000317 Catalog Number :

Device Class : 2

Duns Number: 689700711

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

ACCUNIQ - 08805116000454 Catalog Number :

Device Class : 2

Duns Number: 689700711

Premarket Exempt : Yes

Product Code : PUH

Prescription Use : No

Device Count : 1

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