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Non Contact Infrared Body Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref HTD8813510(k) K171888
Identity
- Trade Name
- Non Contact Infrared Body Thermometer EUDAMED
- Device Name
- Non Contact Infrared Body Thermometer EUDAMED
- Model / Reference
- HTD8813 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970289032082 EUDAMED
- Basic UDI-DI
- B-06970289032082 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
Non Contact 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171888 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970289032082 | 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 (2)
- EUDAMED 66d3de15-f02b-4405-9f97-a1461d9b4c70 85 fields · synced Jun 18, 2026
- FDA 510(k) K171888 1 fields · synced May 18, 2026