Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

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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) (5) Thermometer, Electronic, Clinical (FLL) (4) Analyzer, Body Composition, Exempt (PUH) (1)

Premarket Exempt

No Yes

Clear

cofoe - 06947468500243 Catalog Number :

Device Description : Bathroom Scale

Device Class : 2

Duns Number: 529903321

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

cofoe - 06947468500274 Catalog Number :

Device Description : Bathroom Scale

Device Class : 2

Duns Number: 529903321

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

BELTER - 06947468500281 Catalog Number :

Device Description : Blood Pressure Meter

Device Class :

Duns Number: 529903321

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

doctorgram - 06947468500298 Catalog Number :

Device Description : Blood pressure monitor

Device Class :

Duns Number: 529903321

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

B WELL - 06947468500304 Catalog Number :

Device Description : Body temperature

Device Class :

Duns Number: 529903321

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

B WELL - 06947468500311 Catalog Number :

Device Description : Wall Mt Forehead Thermometer

Device Class :

Duns Number: 529903321

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

doctorgram - 06947468500328 Catalog Number :

Device Description : Thermometer

Device Class :

Duns Number: 529903321

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

biotricity - 06947468500335 Catalog Number :

Device Description : this is a Thermometer.

Device Class :

Duns Number: 529903321

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

biotricity - 06947468500342 Catalog Number :

Device Description : Blood pressure monitor

Device Class :

Duns Number: 529903321

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

truME - 06947468500359 Catalog Number :

Device Description : D321077

Device Class :

Duns Number: 529903321

Premarket Exempt : No

Product Code : PUH

Prescription Use : No

Device Count : 1

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