Identity
- Trade Name
- SIMZO EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- HW-F3 EUDAMEDHW-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959989100352 EUDAMED06959989110030 EUDAMED
- Basic UDI-DI
- B-06959989100352 EUDAMEDB-06959989110030 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Simzo by Dongguan SIMZO Electronic Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06959989100352 | 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 (2)
- EUDAMED 20c346fe-bf8f-46a6-b39d-a0586f6cbd46 61 fields · synced Jul 13, 2026
- EUDAMED 3d9413a7-727c-48be-818b-940d5ae6495e 61 fields · synced May 18, 2026