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Non-contacted Infrared forehead thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IR-05MT
Identity
- Trade Name
- Non-contacted Infrared forehead thermometer EUDAMEDInnospire Deluxe FDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Device Name
- Non-contacted Infrared Forehead Thermometer EUDAMED1110059 FDA UDI
- Model / Reference
- IR-05MT EUDAMED1110059 FDA UDI
- Description
- 1110059 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946159502078 EUDAMEDFDA UDI
- Basic UDI-DI
- 69461595IRHA EUDAMED
- Direct Marketing DI
- 06946159502078 EUDAMED
- 510(k) Number
- K031413 FDA UDI
- FDA Product Code
- CAF FDA UDIBTI FDA UDI
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
- GMDN Term
- Medical device air compressor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI868.6250 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Non-contacted Infrared forehead thermometer by Vega Technologies Inc. — 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 | 69461595IRHA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Vega Technologies Inc.
- EUDAMED SRN
- CN-MF-000012927
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 9798065b-a5c4-43b8-99df-945653bb4493 61 fields · synced Jul 16, 2026
- FDA UDI 6785243c-584d-427b-87dd-477133eeabd5 34 fields · synced May 30, 2026