Fanmi

FDA UDI

Class II (US FDA UDI)

by Alicn Medical Shenzhen, Inc.

Identity

Trade Name: FANMI FDA UDI
Generic Name: Infrared patient thermometer, ear FDA UDI
Device Name: Black FDA UDI
Model / Reference: AET-R151 FDA UDI
Description: Black FDA UDI

Identifiers

Primary DI / UDI-DI: 06953775661737 FDA UDI
510(k) Number: K210564 FDA UDI
FDA Product Code: SDV FDA UDI
GMDN Term: Infrared patient thermometer, ear FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Infrared patient thermometer, ear

Fanmi by Alicn Medical Shenzhen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class II
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Cleared under the same submission

K210564 also covers:

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: Alicn Medical Shenzhen, Inc.

Sources (1)

FDA UDI e5e6149d-6835-4fc5-be7c-10c8de77aa45 34 fields · synced May 30, 2026