Dr.Tempzone+

FDA UDI

Class I (US FDA UDI)

by One Power

Identity

Trade Name: Dr.Tempzone+ FDA UDI
Generic Name: Colour-indication patient thermometer FDA UDI
Device Name: Thermometer, colour-indicating FDA UDI
Model / Reference: DR-TZ-US2 FDA UDI
Description: Thermometer, colour-indicating FDA UDI

Identifiers

Primary DI / UDI-DI: 08800105200020 FDA UDI
FDA Product Code: FQZ FDA UDI
GMDN Term: Colour-indication patient thermometer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.2900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Colour-indication patient thermometer

Dr.Tempzone+ by One Power — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Colour-indication patient thermometer.

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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 I	Pending data

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Manufacturer

Manufacturer: One Power

Sources (1)

FDA UDI 796e0d2c-de28-478b-9d8d-ab0f0c7d3362 33 fields · synced May 31, 2026