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Digital Thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AOJ-25BModel AOJ-25A，AOJ-25B，AOJ-25C，AOJ-25D，AOJ-25E
Identity
- Trade Name
- Digital Thermometer EUDAMEDfridababy FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Digital thermometer EUDAMED
- Model / Reference
- AOJ-25A，AOJ-25B，AOJ-25C，AOJ-25D，AOJ-25E EUDAMEDAOJ-25B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972040111432 EUDAMEDFDA UDI
- Basic UDI-DI
- 697204011AOJ25X17Z EUDAMED
- Direct Marketing DI
- 06972040111432 EUDAMED
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
- GMDN Term
- Intermittent electronic patient thermometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Digital Thermometer by Shenzhen AOJ Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697204011AOJ25X17Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 49a00db6-2f79-4813-9f16-7378f0edb428 61 fields · synced Oct 5, 2026
- FDA UDI 83b26c5e-cfb5-4837-907e-dcb0da39f69d 33 fields · synced May 30, 2026