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Simzo

FDA UDI

Class II (US FDA UDI)

by Dongguan SIMZO Electronic Technology Co., Ltd.

Identity

Trade Name
SIMZO FDA UDI
Generic Name
Infrared patient thermometer, skin FDA UDI
Model / Reference
HW-F7 FDA UDI

Identifiers

Primary DI / UDI-DI
00810021171203 FDA UDI
510(k) Number
K173048 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Infrared patient thermometer, skin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Simzo by Dongguan SIMZO Electronic Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K173048 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dongguan SIMZO Electronic Technology Co., Ltd.

Sources (1)

  • FDA UDI 00cc39ae-b8fd-4e87-814a-2e5fd19f13c3 34 fields · synced May 30, 2026