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Fore Health Probe Cover for Infrared Ear Thermometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref IR20
Identity
- Trade Name
- Fore Health Probe Cover for Infrared Ear Thermometer EUDAMEDActherm FDA UDI
- Generic Name
- Electronic thermometer probe cover FDA UDI
- Device Name
- Probe Cover for Infrared Ear Thermometer EUDAMED
- Model / Reference
- IR20 EUDAMEDProbe Cover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972325561266 EUDAMEDFDA UDI
- Basic UDI-DI
- 697232556A00003V4 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V030180 BODY TEMPERATURE MEASURING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Electronic thermometer probe cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Fore Health Probe Cover for Infrared Ear Thermometer by Dongguan Actherm Medical Corp. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697232556A00003V4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dongguan Actherm Medical Corp.
- EUDAMED SRN
- CN-MF-000021940
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 026a9212-68fb-449d-b76b-d2ae16f74b43 61 fields · synced Jul 13, 2026
- FDA UDI 77736ba0-f51e-4c3a-82a5-9cbd77a4d9f2 32 fields · synced May 30, 2026