Identity
- Trade Name
- Infrared Forehead Thermometer EUDAMED
- Device Name
- Infrared Forehead Thermometer EUDAMED
- Model / Reference
- HW-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16959989115018 EUDAMED
- Basic UDI-DI
- 69599891XZFIR0001N8 EUDAMED
- Direct Marketing DI
- 16959989115018 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Infrared Forehead Thermometer by Dongguan SIMZO Electronic Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69599891XZFIR0001N8 | Class IIa | Active |
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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 (1)
- EUDAMED 6b27b565-e820-48a6-8066-4a510f280aa1 61 fields · synced Jun 19, 2026