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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
Meditherm IRIS digital thermal camera FDA UDI
Thermal Imaging Camera FDA UDI
Model / Reference
IRIS 640 FDA UDI
Description
Meditherm IRIS digital thermal camera FDA UDI
Thermal Imaging Camera FDA UDI

Identifiers

Catalog Number
1706400 FDA UDI
Primary DI / UDI-DI
B783706400170601147 FDA UDI
B783706400170601151 FDA UDI
B7837064001 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 UDIFDA 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 (3)

  • FDA UDI 99c756a3-0378-4e66-b01f-ac04a594f461 36 fields · synced Jun 1, 2026
  • FDA UDI 08b57b97-1370-4e9c-9c69-6d0587afcec5 36 fields · synced May 25, 2026
  • FDA UDI dc513f6e-ed9f-4550-9af4-5b187094ba44 36 fields · synced May 27, 2026