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Infrared forehead thermometers
EUDAMEDClass IIa (EU MDR)
Ref HS-MKB-024Model HFS-1000
Identity
- Trade Name
- Infrared forehead thermometers EUDAMED
- Device Name
- Thermofinder Plus EUDAMED
- Model / Reference
- HFS-1000 EUDAMEDHS-MKB-024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800132200277 EUDAMED
- Basic UDI-DI
- 88001322TH000054 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Infrared forehead thermometers by HuBDIC Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88001322TH000054 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HuBDIC Co., Ltd
- EUDAMED SRN
- KR-MF-000014142
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (1)
- EUDAMED 3c89a507-a0f7-4af0-9fe7-45cb8a1a420f 61 fields · synced May 23, 2026