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Infrared Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AOJ-20AModel AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20Y, AOJ-20R510(k) K182133
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-20A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040110336 EUDAMED
- Basic UDI-DI
- 697204011AOJ20X178 EUDAMED
- Direct Marketing DI
- 06972040110336 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182133 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697204011AOJ20X178 | Class IIa | Unknown |
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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 (2)
- EUDAMED 84be2911-c10b-429b-b700-181918de6fb6 85 fields · synced Jun 18, 2026
- FDA 510(k) K182133 1 fields · synced May 18, 2026