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Infrared Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref /Model IT-122, IT-123, IT-124, IT-126, IT-127, IT-128, IT-129, IT-133, IT-901, IT-913, IT-915, IT-916, IT-917, IT-918, IT-919, IT-920, IT-121S
Identity
- Trade Name
- Infrared Thermometer EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- IT-122, IT-123, IT-124, IT-126, IT-127, IT-128, IT-129, IT-133, IT-901, IT-913, IT-915, IT-916, IT-917, IT-918, IT-919, IT-920, IT-121S EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926347900350 EUDAMED06926347941506 EUDAMED06926347900336 EUDAMED05719807346604 EUDAMED06427416165262 EUDAMED06926347900428 EUDAMED
- Basic UDI-DI
- 69263479IT101QL EUDAMED
- Direct Marketing DI
- 06926347900350 EUDAMED06926347941506 EUDAMED06926347900336 EUDAMED06427416165262 EUDAMED06926347900428 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMEDZ1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDSpain EUDAMEDDenmark EUDAMEDRomania EUDAMEDPoland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infrared Thermometer by Shenzhen Brav Electronic Technologies Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171214 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69263479IT101QL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Brav Electronic Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000021859
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (7)
- EUDAMED 8df89325-8e46-42ec-b52e-76d4fd321e9a 61 fields · synced Aug 2, 2026
- EUDAMED 2181173a-7e03-40d2-8758-550124eaa2eb 61 fields · synced May 17, 2026
- EUDAMED d6a4bd7d-905e-4857-a1c8-aac4e2a2b0e0 61 fields · synced May 17, 2026
- EUDAMED 6134ca96-8ca9-4eef-afab-872b05eb54fc 61 fields · synced May 18, 2026
- EUDAMED 0d14309f-9892-49e6-9465-181437b4a1f7 61 fields · synced May 19, 2026
- EUDAMED b3864183-d2c2-48b3-bb13-2fe4049d247d 61 fields · synced Aug 2, 2026
- FDA 510(k) K171214 1 fields · synced May 18, 2026