Identity
- Trade Name
- SMARTRO FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- EFT-161 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode,and ear temperature mode. The measurement result directly shows on the LCD screen, It is easy, hygiene and accurate. The device is widely used for home healthcare, medical institutes and many other occasions. FDA UDI
- Model / Reference
- EFT-161 FDA UDI
- Description
- EFT-161 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode,and ear temperature mode. The measurement result directly shows on the LCD screen, It is easy, hygiene and accurate. The device is widely used for home healthcare, medical institutes and many other occasions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06926347911615 FDA UDI
- 510(k) Number
- K171214 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared patient thermometer, ear
Smartro by Shenzhen Brav Electronic Technologies Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared patient thermometer, ear.
- Famidoc — Famidoc Technology Company Limited · Class II
- Braun — KAZ USA, INC. · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
- Braun — KAZ USA, INC. · Class II
- Bytech — Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. · Class II
- WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 — GOLDEN SMART HOME TECHNOLOGY CORP. · Class II
- Easy@Home Infrared Ear Thermometers — EASY HEALTHCARE CORPORATION · Class II
- Clever Choice — SIMPLE DIAGNOSTICS · Class II
Cleared under the same submission
K171214 also covers:
- ProCare IR Thermometer — ARISE MEDICAL LLC
- Bjingles — NK AMERICAN WAY, LLC
- Bjingles — NK AMERICAN WAY, LLC
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- BRAV — Shenzhen Brav Electronic Technologies Co., Ltd.
- North American Health Wellness — Shenzhen Brav Electronic Technologies Co., Ltd.
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
- Shenzhen Brav Electronic Technologies Co., Ltd.
Sources (1)
- FDA UDI ff70880d-f43d-4379-bc35-5ffd62e90fc7 34 fields · synced May 30, 2026