Mio Labs Inc.

Address:#1023, ZGC Innovation Center,4500 Great America Pkwy,Santa Clara,CA,95054,US

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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, Test, Blood Glucose, Over The Counter (NBW) (5) Scale, Stand-On, Patient (FRI) (1)

Premarket Exempt

No Yes

Clear

MIO - 00850042929001 Catalog Number : TeleBGM Gen-1(BLE)

Device Description : Blood Glucose Meter

Device Class : 2

Duns Number: 117119317

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

MIO - 00850042929018 Catalog Number : TeleBGM Test Strip

Device Description : Blood Glucose Test Strip

Device Class : 2

Duns Number: 117119317

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

MIO - 00850042929025 Catalog Number : TeleBGM Control Solution

Device Description : Mio Control Solution

Device Class : 2

Duns Number: 117119317

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

MIO - 00850042929032 Catalog Number :

Device Description : Mio Single Use Lancets

Device Class : 2

Duns Number: 117119317

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

MIO - 00850042929049 Catalog Number : TeleBGM Lancing Device

Device Description : Mio Lancing Device

Device Class : 2

Duns Number: 117119317

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

MIO - 00850042929070 Catalog Number :

Device Class : 1

Duns Number: 117119317

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

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