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Ear Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref EAR-E101Model EAR-E101, EAR-E102, EAR-E103
Identity
- Trade Name
- Ear Thermometer EUDAMED
- Device Name
- Ear Thermometer EUDAMED
- Model / Reference
- EAR-E101, EAR-E102, EAR-E103 EUDAMEDEAR-E101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040112095 EUDAMED
- Basic UDI-DI
- 697204011E10X7V EUDAMED
- Direct Marketing DI
- 06972040112095 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
Ear 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 Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250470 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697204011E10X7V | 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 (2)
- EUDAMED 0b77cc00-7676-4a3d-bf86-e4549c2fd539 61 fields · synced Oct 6, 2026
- FDA 510(k) K250470 1 fields · synced May 18, 2026