HEALTH & LIFE CO., LTD.

Address:9F, NO.186, JIAN YI ROAD,Zhonghe District, New Taipei City,TW

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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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (6) Nebulizer (Direct Patient Interface) (CAF) (3) Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (CCQ) (1)

Premarket Exempt

Yes No

Clear

HM01 - 04719872483274 Catalog Number :

Device Description : Arm type blood pressure monitor

Device Class : 2

Duns Number: 657836743

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Sunbean - 04719872483298 Catalog Number :

Device Description : Upper Arm Blood Pressure Monitor

Device Class : 2

Duns Number: 657836743

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Clinical Guard - 04719872486022 Catalog Number :

Device Description : Nebulizer

Device Class :

Duns Number: 657836743

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

eMist - 04719872486039 Catalog Number :

Device Description : Nebulizer

Device Class : 2

Duns Number: 657836743

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

ALERTCARE - 04719872486046 Catalog Number :

Device Description : Nebulizer

Device Class :

Duns Number: 657836743

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

North American Health & Wellness - 04719872488507 Catalog Number :

Device Description : Atomizer

Device Class :

Duns Number: 657836743

Premarket Exempt : Yes

Product Code : CCQ

Prescription Use : No

Device Count : 1

N/A - 04719872489016 Catalog Number :

Device Description : Blood pressure cuff of the blood pressure monitor

Device Class : 2

Duns Number: 657836743

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

N/A - 04719872489023 Catalog Number :

Device Description : Blood pressure cuff of the blood pressure monitor

Device Class : 2

Duns Number: 657836743

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

N/A - 04719872489030 Catalog Number :

Device Description : Standard Size Cuff with Connector for BPA-040

Device Class : 2

Duns Number: 657836743

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

N/A - 04719872489047 Catalog Number :

Device Description : Blood pressure cuff of the blood pressure monitor

Device Class : 2

Duns Number: 657836743

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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