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Exergen TemporalScannerTM Thermometer
EUDAMEDClass IIa (EU MDR)
Ref TAT-5000S-232EPModel TAT-5000S
Identity
- Trade Name
- Exergen TemporalScannerTM Thermometer EUDAMED
- Device Name
- Exergen TemporalScanner Thermometer TAT-5000S EUDAMED
- Model / Reference
- TAT-5000S EUDAMEDTAT-5000S-232EP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00834098000532 EUDAMED
- Basic UDI-DI
- 083409800TAT5000SE3 EUDAMED
- Direct Marketing DI
- 00834098000532 EUDAMED
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Exergen TemporalScannerTM Thermometer by Exergen Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 083409800TAT5000SE3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Exergen Corporation
- EUDAMED SRN
- US-MF-000011488
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 9bf6a434-7af5-4500-9b95-750c0d5a1ecc 61 fields · synced Jun 9, 2026