Identity
- Trade Name
- Infrared Forehead Thermometer EUDAMEDSIMZO FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Infrared Forehead Thermometer EUDAMED
- Model / Reference
- HW-F4 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959989110108 EUDAMED00810021171111 FDA UDI
- Basic UDI-DI
- 69599891XZFIR0001N8 EUDAMED
- Direct Marketing DI
- 06959989110108 EUDAMED
- 510(k) Number
- K173048 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Infrared Forehead Thermometer by Dongguan SIMZO Electronic Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69599891XZFIR0001N8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dongguan SIMZO Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015642
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED e423697b-c9ab-42bc-b5df-92ac1660741d 61 fields · synced Jul 19, 2026
- FDA UDI 3696bf44-0754-46bc-9c2d-6133e8303a6e 33 fields · synced May 30, 2026