MIO / TeleRPM

FDA UDI

Class II (US FDA UDI)

by Mio Labs Inc.

Identity

Trade Name: MIO / TeleRPM FDA UDI
Generic Name: Glucose analyser IVD, home-use FDA UDI
Device Name: Mio Lancing Device FDA UDI
Model / Reference: HH-XIII-T FDA UDI
Description: Mio Lancing Device FDA UDI

Identifiers

Catalog Number: TeleBGM Lancing Device FDA UDI
Primary DI / UDI-DI: 00850042929049 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose analyser IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose analyser IVD, home-use

MIO / TeleRPM by Mio Labs Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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VivaGuard Ino Smart Blood Glucose Meter — ABOUND Diagnostics, Inc · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mio Labs Inc.

Sources (1)

FDA UDI 168df975-ea3f-4e9e-9aa6-cab7b18be48b 34 fields · synced May 29, 2026