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Health Wealth Safe

FDA UDI

Class II (US FDA UDI)

by Mio Labs Inc.

Identity

Trade Name
Health Wealth Safe FDA UDI
Generic Name
Blood glucose/blood pressure monitoring system, home-use FDA UDI
Device Name
Blood Glucose Test Strip FDA UDI
Model / Reference
TTS01 FDA UDI
Description
Blood Glucose Test Strip FDA UDI

Identifiers

Primary DI / UDI-DI
00850042929339 FDA UDI
FDA Product Code
NBW FDA UDI
GMDN Term
Blood glucose/blood pressure monitoring system, 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood glucose/blood pressure monitoring system, home-use

Health Wealth Safe by Mio Labs Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood glucose/blood pressure monitoring system, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mio Labs Inc.

Sources (1)

  • FDA UDI 9996f73f-f68d-47d1-b2ab-7d1fbad02407 33 fields · synced May 30, 2026