ANDESFIT LIMITED

ANDESFIT LIMITED

Address:Unit 513 Lakeside 1, No.8 Science Park West Ave., Hong Kong Science Park, Hong Kong,HKG,HK

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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

Oximeter (DQA) (2) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2) System, Test, Blood Glucose, Over The Counter (NBW) (2) Thermometer, Electronic, Clinical (FLL) (2) Oximeter, Wellness (PGJ) (1) Glucose Oxidase, Glucose (CGA) (1) Meter, Peak Flow, Spirometry (BZH) (1) Analyzer, Body Composition (MNW) (1)

Premarket Exempt

No

Clear

Andesfit - 00146191010005 Catalog Number :

Device Description : Wireless Spirometer

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Andnesfit Health - 00146191200505 Catalog Number :

Device Description : Wireless pulse oximeter

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : DQA, PGJ

Prescription Use : No

Device Count : 1

Andesfit - 00146191200604 Catalog Number :

Device Description : Wireless Pules Oximeter

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Andesfit - 00146191201908 Catalog Number :

Device Description : Wireless Arm Type Blood Pressure monitor

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Andnesfit Health - 00146191202707 Catalog Number :

Device Description : Blood Glucose Monitoring System

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Andnesfit Health - 00146191202776 Catalog Number :

Device Description : Blood Glucose Test Strip

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Andnesfit Health - 00146191203407 Catalog Number :

Device Description : Wireless Infrared Ear/Forehead Thermometer

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Andesfit - 00146191203803 Catalog Number :

Device Description : Wireless Non-Contact Infrared Body/Surface Thermometer

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Andesfit - 00146191210221 Catalog Number :

Device Description : Wireless Wrist Type Blood Pressure Monitor

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Andnesfit Health - 00146191288527 Catalog Number :

Device Description : ITO Wireless Body Fat Scale

Device Class : 2

Duns Number: 664101036

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

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