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Exergen TemporalScannerTM Thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 124263Model TAT-5000SRef 124234-AF-GNRef 124388Ref 124006Ref 124004Ref 124283SRef 124001Ref 124231-AF-GNRef 140001, 140023Model TAT-2000 and TAT-2000-ECRef 124386Ref 124003Ref 124236-AC-GNRef 124399Ref 124234-OF-GN Ref 124234-AC-GNRef 124005Ref 140008Model TAT-2000C and TAT-2000C-ECRef 124257
Identity
- Trade Name
- Exergen TemporalScannerTM Thermometer EUDAMEDExergen Temporal Scanner FDA UDIExergen Temporal Scanner™ FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Exergen TemporalScanner Thermometer TAT-5000S EUDAMEDExergen TemporalScanner Thermometer TAT-2000 EUDAMEDExergen TemporalScanner Thermometer TAT-2000C EUDAMEDTAT2000C Temporal Scanner FDA UDITAT2000 Temporal Scanner FDA UDI
- Model / Reference
- TAT-5000S EUDAMED124263 EUDAMED124234-AF-GN EUDAMED124388 EUDAMED124006 EUDAMED124004 EUDAMED124283S EUDAMED124001 EUDAMED124231-AF-GN EUDAMEDTAT-2000 and TAT-2000-EC EUDAMED140001, 140023 EUDAMED124386 EUDAMED124003 EUDAMED124236-AC-GN EUDAMED124399 EUDAMED124234-OF-GN EUDAMED124234-AC-GN EUDAMED124005 EUDAMEDTAT-2000C and TAT-2000C-EC EUDAMED140008 EUDAMED124257 EUDAMEDTAT2000C FDA UDITAT2000 FDA UDI
- Description
- TAT2000C Temporal Scanner FDA UDITAT2000 Temporal Scanner FDA UDI
Identifiers
- Catalog Number
- 140008 FDA UDI140001, 140023 FDA UDI
- Primary DI / UDI-DI
- 00834098000259 EUDAMED00834098001089 EUDAMED00834098000648 EUDAMED00834098000198 EUDAMED00834098000204 EUDAMED00834098000990 EUDAMED00834098000280 EUDAMED00834098000488 EUDAMED00834098002055 EUDAMED00834098001041 EUDAMED00834098000181 EUDAMED00834098001195 EUDAMED00834098001232 EUDAMED00834098002062 EUDAMEDFDA UDI00834098001218 EUDAMED00834098001072 EUDAMED00834098000211 EUDAMED00834098000471 EUDAMED10834098002052 FDA UDI
- Basic UDI-DI
- 083409800TAT5000SE3 EUDAMED083409800TAT20007W EUDAMED083409800TAT2000CC2 EUDAMED
- Direct Marketing DI
- 00834098000259 EUDAMED00834098001089 EUDAMED00834098000648 EUDAMED00834098000198 EUDAMED00834098000204 EUDAMED00834098000990 EUDAMED00834098000280 EUDAMED00834098000488 EUDAMED00834098002055 EUDAMED00834098001041 EUDAMED00834098000181 EUDAMED00834098001195 EUDAMED00834098001232 EUDAMED00834098001218 EUDAMED00834098001072 EUDAMED00834098000211 EUDAMED00834098002062 EUDAMED00834098000471 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 EUDAMEDTürkiye EUDAMEDIreland EUDAMEDNetherlands 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
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 (21)
- EUDAMED ce2a0d7b-6f44-4a72-87f7-df2d5f0f4b07 61 fields · synced Sep 18, 2026
- EUDAMED 75882bc9-dc9c-41b2-b113-87f09d402f53 61 fields · synced May 16, 2026
- EUDAMED 1ef064f6-38d5-4b92-8cbf-b7728818c31c 61 fields · synced May 17, 2026
- EUDAMED bb2d1c2b-a147-4174-8f29-ab6e7c348afa 61 fields · synced May 17, 2026
- EUDAMED 250c25f6-b15a-41c5-bfb8-fcddd6ff512c 61 fields · synced May 17, 2026
- EUDAMED 13029e2b-e0c0-4682-adeb-bd245cd35ab5 61 fields · synced May 17, 2026
- EUDAMED d8d8258c-2037-428f-af1c-93dbf1813489 61 fields · synced May 18, 2026
- EUDAMED f9d0b205-1351-4ff9-b208-6de7a1be704d 61 fields · synced May 18, 2026
- EUDAMED 879901f2-76ee-45d6-8a9c-d8e9fd653ee1 61 fields · synced May 18, 2026
- EUDAMED 0ebc2a16-cf1b-4745-bc6b-642c92084bd2 61 fields · synced May 18, 2026
- EUDAMED 7943666a-bd35-4dd5-958d-81ca2de2fcf4 61 fields · synced May 18, 2026
- EUDAMED df838ea5-2f8f-4a5c-a21d-53f0a3b9af6c 61 fields · synced May 18, 2026
- EUDAMED 6dd0e5c6-2bbb-41bf-8fc9-36cb251cb38f 61 fields · synced May 18, 2026
- FDA UDI f0c5879d-ef9a-4fca-9b08-662525a25acb 37 fields · synced May 29, 2026
- FDA UDI 2e0c8124-2929-4625-b001-7eafeb7a3bb6 37 fields · synced May 29, 2026
- EUDAMED dd59ac0b-1dea-45d8-bb70-152a062d4be0 61 fields · synced Jun 20, 2026
- EUDAMED 01fee2f1-5121-4bcc-99d7-e5865be852ab 61 fields · synced Jul 10, 2026
- EUDAMED a358cacd-084f-4040-9812-09d380ddf0db 61 fields · synced Jul 19, 2026
- EUDAMED 879901f2-76ee-45d6-8a9c-d8e9fd653ee1-1 61 fields · synced Jul 20, 2026
- EUDAMED 5d6b84e4-5f56-496b-8305-7b664ea55369 61 fields · synced Jul 26, 2026
- EUDAMED 3b707103-7e6b-4ad2-9724-dfbafc9ae030 61 fields · synced Sep 18, 2026