Elate

FDA UDI

Class II (US FDA UDI)

by Amplim, Llc

Identity

Trade Name: Elate FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Model / Reference: AL1 FDA UDI

Identifiers

Primary DI / UDI-DI: 00810477028052 FDA UDI
510(k) Number: K210565 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: 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

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Infrared patient thermometer, skin

Elate by Amplim, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, skin.

TytoHome — TYTO CARE LTD · Class II
ALPHAMED — Shenzhen Urion Technology Co., Ltd. · Class II
Diagnostix™ — American Diagnostic Corporation · Class II
Famidoc — FAMIDOC USA, INC. · Class II
Sinocare Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Famidoc — Famidoc Technology Company Limited · Class II
DR.TALBOT'S Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Berrcom — Guangzhou Berrcom Medical Device Co., Ltd · Class II

Cleared under the same submission

K210565 also covers:

AMPMED — AMPLIM, LLC
AMPMED — AMPLIM, LLC
AMPMED — AMPLIM, LLC
AMPMED — AMPLIM, LLC
Elate — AMPLIM, LLC
Direct Supply Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc.

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: Amplim, Llc

Sources (1)

FDA UDI 589a94ce-2df6-4360-9b95-dfe01b45a2ec 33 fields · synced May 30, 2026