Identity
- Device Name
- Infrared Body Thermometer EUDAMED
- Model / Reference
- HTD8219EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HTD8219EU42 EUDAMED
- Basic UDI-DI
- B-HTD8219EU42 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Infrared Body Thermometer by Hetaida 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-HTD8219EU42 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hetaida Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032793
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 52f3e095-328e-4719-a540-bef391a0d2a8 61 fields · synced May 23, 2026