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Meditherm

FDA UDI

Class I (US FDA UDI)

by Meditherm Incorporated

Identity

Trade Name
Meditherm FDA UDI
Generic Name
Infrared thermography system FDA UDI
Device Name
Digital thermal camera FDA UDI
Model / Reference
IRIS 640 FDA UDI
Description
Digital thermal camera FDA UDI

Identifiers

Catalog Number
1706400 FDA UDI
Primary DI / UDI-DI
B783706400170601138 FDA UDI
510(k) Number
K003332 FDA UDI
FDA Product Code
LHQ FDA UDI
GMDN Term
Infrared thermography system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.2980 FDA UDI
Commercial Distribution
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Infrared thermography system

Meditherm by Meditherm Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared thermography system.

Cleared under the same submission

K003332 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meditherm Incorporated

Sources (1)

  • FDA UDI e3aa0e82-adda-4132-a561-90b35e31abae 36 fields · synced May 31, 2026