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Infrared Body Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref HTD8819Ref HTD8222EURef HTD8216CRef HTD8818A
Identity
- Trade Name
- Infrared Body Thermometer EUDAMED
- Device Name
- Infrared Body Thermometer EUDAMED
- Model / Reference
- HTD8819 EUDAMEDHTD8222EU EUDAMEDHTD8216C EUDAMEDHTD8818A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HTD8819WB EUDAMEDD-HTD8222EU36 EUDAMED06970289032099 EUDAMEDD-HTD8818AFV EUDAMED
- Basic UDI-DI
- B-HTD8819WB EUDAMEDB-HTD8222EU36 EUDAMEDB-06970289032099 EUDAMEDB-HTD8818AFV 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 — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200781 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180385 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-HTD8819WB | 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 (5)
- EUDAMED 8cc46838-6d82-45a3-b310-7832fa714c60 61 fields · synced Jul 30, 2026
- EUDAMED 28cf70f1-0a96-4454-8881-f9a306d8bd8c 61 fields · synced May 18, 2026
- EUDAMED fc7b800a-504d-407b-aca1-174af4832479 61 fields · synced May 18, 2026
- EUDAMED 34294909-75e4-4550-b17e-f541a43eb998 61 fields · synced Jul 13, 2026
- FDA 510(k) K200781 1 fields · synced May 18, 2026