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Digital thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AOJ-25AModel AOJ-25A，AOJ-25B，AOJ-25C，AOJ-25D，AOJ-25ERef AOJ-25E510(k) K213485Ref AOJ-25D
Identity
- Trade Name
- Digital thermometer EUDAMED
- Device Name
- Digital thermometer EUDAMED
- Model / Reference
- AOJ-25A，AOJ-25B，AOJ-25C，AOJ-25D，AOJ-25E EUDAMEDAOJ-25A EUDAMEDAOJ-25E EUDAMEDAOJ-25D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040110657 EUDAMED06972040110886 EUDAMED06972040110862 EUDAMED
- Basic UDI-DI
- 697204011AOJ25X17Z EUDAMED
- Direct Marketing DI
- 06972040110657 EUDAMED06972040110886 EUDAMED06972040110862 EUDAMED
- 510(k) Number
- K213485 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Digital 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 | K213485 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697204011AOJ25X17Z | 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 (4)
- EUDAMED f5abca71-039a-4228-ba5b-aec0cc6085a0 61 fields · synced Oct 6, 2026
- EUDAMED 925aa424-6431-4cf5-ae64-3562c9395876 61 fields · synced May 17, 2026
- FDA 510(k) K213485 24 fields · synced May 18, 2026
- EUDAMED c00f9a42-4123-47e8-9e55-1e74bf015270 61 fields · synced Jul 29, 2026