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Exergen TemporalScannerTM Thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 124227-OC-GEModel TAT-5000S
Identity
- Trade Name
- Exergen TemporalScannerTM Thermometer EUDAMEDExergen Temporal Scanner FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Exergen TemporalScanner Thermometer TAT-5000S EUDAMEDTAT-5000S-USB-GE2, ORAL, DEG C FDA UDI
- Model / Reference
- TAT-5000S EUDAMED124227-OC-GE EUDAMEDTAT-5000S-USB-GE2 FDA UDI
- Description
- TAT-5000S-USB-GE2, ORAL, DEG C FDA UDI
Identifiers
- Catalog Number
- 124227-OC-GE FDA UDI
- Primary DI / UDI-DI
- 00834098000624 EUDAMED10834098000614 FDA UDI
- Basic UDI-DI
- 083409800TAT5000SE3 EUDAMED
- Direct Marketing DI
- 00834098000624 EUDAMED
- 510(k) Number
- K011291 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMED
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Denmark 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Exergen TemporalScannerTM Thermometer by Exergen Corporation — 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 | 083409800TAT5000SE3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exergen Corporation
- EUDAMED SRN
- US-MF-000011488
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 330bcdae-0899-4a9f-8b5d-238390c1fc88 61 fields · synced Jun 9, 2026
- FDA UDI 4c529d4c-b8ed-432c-a333-0aaa3cbac180 37 fields · synced May 30, 2026