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Tecnimed - Hammacher

FDA UDI

Class II (US FDA UDI)

by Tecnimed Srl

Identity

Trade Name
Tecnimed - Hammacher FDA UDI
Generic Name
Infrared patient thermometer, skin FDA UDI
Device Name
Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages FDA UDI
Model / Reference
VisioFocus FDA UDI
Description
Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages FDA UDI

Identifiers

Catalog Number
06400 FDA UDI
Primary DI / UDI-DI
00182097000689 FDA UDI
510(k) Number
K122412 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

Yes

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

Tecnimed - Hammacher by Tecnimed Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K122412 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tecnimed Srl

Sources (1)

  • FDA UDI 3d427329-64f0-4b64-bdae-3da0a446a8b4 37 fields · synced May 31, 2026