Identity
- Trade Name
- Infrared Thermometer EUDAMEDCEM FDA UDI
- Generic Name
- Infrared patient thermometer, ear/skin FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- DT-8806 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06951110988051 EUDAMEDFDA UDI
- Basic UDI-DI
- 69511109DT-880667 EUDAMED
- 510(k) Number
- K101736 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
- GMDN Term
- Infrared patient thermometer, ear/skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Infrared patient thermometer, ear/skin
Cem by Shenzhen Everbest Machinery Industry Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Everbest Machinery Industry Co., Ltd.
Sources (2)
- FDA UDI aca744b7-f5ff-4cae-9491-b1e6bfc760cc 34 fields · synced Jul 12, 2026
- EUDAMED 48b270b9-401a-4638-b0ca-4dfee3883682 61 fields · synced Jul 12, 2026