← Back to catalogue
Infrared Forehead Thermometer
EUDAMEDClass IIa (EU MDR)
Ref HW-F2Ref HW-F3Ref HW-2Ref HW-F7Ref HW-F1Ref HW-F5
Identity
- Trade Name
- Infrared Forehead Thermometer EUDAMED
- Device Name
- Infrared Forehead Thermometer EUDAMED
- Model / Reference
- HW-F2 EUDAMEDHW-F3 EUDAMEDHW-2 EUDAMEDHW-F7 EUDAMEDHW-F1 EUDAMEDHW-F5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959989110085 EUDAMED06959989110092 EUDAMED06959989110009 EUDAMED06959989110139 EUDAMED06959989110078 EUDAMED06959989115080 EUDAMED03700445502141 EUDAMED06959989115134 EUDAMED06959989115073 EUDAMED16959989115001 EUDAMED16959989115025 EUDAMED
- Basic UDI-DI
- 69599891XZFIR0001N8 EUDAMEDB-06959989115080 EUDAMEDB-06959989115073 EUDAMED
- Direct Marketing DI
- 06959989110085 EUDAMED06959989110092 EUDAMED06959989110009 EUDAMED06959989110139 EUDAMED06959989110078 EUDAMED03700445502141 EUDAMED06959989115134 EUDAMED16959989115001 EUDAMED16959989115025 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMEDPoland 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69599891XZFIR0001N8 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69599891XZFIR0001N8 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dongguan SIMZO Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015642
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (11)
- EUDAMED 4004f96c-87d8-4440-ac45-8ea3b9188645 61 fields · synced Sep 18, 2026
- EUDAMED 517ec9ac-014e-4258-875d-9d9becdd7baf 61 fields · synced May 17, 2026
- EUDAMED 819f66da-bf3d-4182-92c9-5bebffe0cee4 61 fields · synced May 17, 2026
- EUDAMED 0bdd6e83-70e5-4321-93d7-80d3c02a4957 61 fields · synced May 17, 2026
- EUDAMED 8ac372b8-fb30-4a90-99cf-8ba28ea0e784 61 fields · synced May 17, 2026
- EUDAMED 6f220b9f-0b50-4006-a0c3-8538edf01f0f 61 fields · synced May 18, 2026
- EUDAMED f0f4286a-d2b6-4129-a152-d35f27c5bbb6 61 fields · synced May 19, 2026
- EUDAMED aa744cc6-f90a-4c2d-a1d0-0f5e3b609008 61 fields · synced May 19, 2026
- EUDAMED e26ac7f5-8b3d-429f-b796-88bdf747fa6e 61 fields · synced May 19, 2026
- EUDAMED 462a5c69-0119-4706-a188-d300d53426e1 61 fields · synced Jul 9, 2026
- EUDAMED a201b5ea-0eae-4f0a-96e5-3fbb8e07bcbc 61 fields · synced Jul 28, 2026