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BBLOVE Infrared Thermometer
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref AET-R1D1
Identity
- Trade Name
- BBLOVE Infrared Thermometer EUDAMEDBBLOVE Non-contact Infrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- AET-R1D1 EUDAMEDAET-R1D1-A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06953775658126 EUDAMEDFDA UDI
- Basic UDI-DI
- 69537756R1B1VP EUDAMED
- 510(k) Number
- K180207 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
- Ireland 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BBLOVE Infrared Thermometer by Alicn Medical Shenzhen, Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222248 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K210564 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69537756R1B1VP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alicn Medical Shenzhen, Inc
- EUDAMED SRN
- CN-MF-000001920
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 04e23fc8-a26f-448f-8301-e0ae0d15422e 61 fields · synced Jul 14, 2026
- FDA UDI ba312067-9067-488f-b307-310a3bc8e896 33 fields · synced May 30, 2026
- FDA 510(k) K222248 1 fields · synced May 18, 2026