Identity
- Trade Name
- MEDISANA FDA UDI
- Generic Name
- Infrared patient thermometer, ear/skin FDA UDI
- Device Name
- a hand-held, battery-powered, electronic instrument designed to measure :1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of the site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip.This device is intended for use in the home or healthcare facility. It is a reusable device FDA UDI
- Model / Reference
- TM A75 FDA UDI
- Description
- a hand-held, battery-powered, electronic instrument designed to measure :1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of the site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip.This device is intended for use in the home or healthcare facility. It is a reusable device FDA UDI
Identifiers
- Catalog Number
- 99652 FDA UDI
- Primary DI / UDI-DI
- 04015588996528 FDA UDI
- 510(k) Number
- K102554 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear/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
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
Yes
FDA UDI
Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, ear/skin
Medisana by Medisana GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, ear/skin.
- CHOSEN Infrared Forehead Thermometer — ABOUND Diagnostics, Inc · Class II
- huangirl Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
- FIGHTECH — Shenzhen Urion Technology Co., Ltd. · Class II
- Infrared Thermometer — Shenzhen Pacom Medical Instruments Co., Ltd. · Class II
- Infrared Thermometer — Shenzhen Jumper Medical Equipment Co., Ltd. · Class II
- MOBI — MOBI TECHNOLOGIES, INC. · Class II
- CONAIR CORPORATION — CONAIR LLC. · Class II
- AlphaMed — Shenzhen Urion Technology Co., Ltd. · Class II
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
- Medisana GmbH
Sources (1)
- FDA UDI c643b9db-a226-4824-a66b-ccc718aae273 36 fields · synced May 30, 2026