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Infrared Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AOJ-20TModel AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20Y, AOJ-20R
Identity
- Trade Name
- Infrared Thermometer EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20Y, AOJ-20R EUDAMEDAOJ-20T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040111128 EUDAMED06972040110428 EUDAMED
- Basic UDI-DI
- 697204011AOJ20X178 EUDAMEDB-06972040110428 EUDAMED
- Direct Marketing DI
- 06972040111128 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 Thermometer by Shenzhen AOJ Medical Technology Co., Ltd. — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697204011AOJ20X178 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232128 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221039 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697204011AOJ20X178 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen AOJ Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018386
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (3)
- EUDAMED f2473170-dcb9-4cc0-b764-6b4724eb753e 61 fields · synced Oct 7, 2026
- EUDAMED 38d9be74-8a8f-4efc-8dd9-d1376d2e0e04 61 fields · synced Jul 20, 2026
- FDA 510(k) K232128 1 fields · synced May 18, 2026