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Infrared forehead thermometers
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HS-MKB-034Model HFS-700Ref HS-MKB-002Model FS-700
Identity
- Trade Name
- Infrared forehead thermometers EUDAMEDThermofinder S FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Thermofinder S2 EUDAMEDThermofinder S EUDAMEDThe Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD. FDA UDI
- Model / Reference
- HFS-700 EUDAMEDHS-MKB-034 EUDAMEDFS-700 EUDAMEDFDA UDIHS-MKB-002 EUDAMED
- Description
- The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800132200291 EUDAMED08800132200239 EUDAMEDFDA UDI
- Basic UDI-DI
- 88001322TH000258 EUDAMED88001322TH000156 EUDAMED
- 510(k) Number
- K130361 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Infrared forehead thermometers by HuBDIC Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88001322TH000258 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- HuBDIC Co., Ltd
- EUDAMED SRN
- KR-MF-000014142
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (3)
- EUDAMED 38951ea8-5d78-4da0-aa87-3b21b196c933 61 fields · synced Jul 9, 2026
- FDA UDI cf7432c0-ee73-4cb4-96b2-7b062bae6ef2 35 fields · synced May 30, 2026
- EUDAMED 01a66692-1d0b-4396-a694-919214cfb75a 61 fields · synced Jul 9, 2026