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Infrared Ear/ Forehead Thermometer
EUDAMEDClass IIa (EU MDR)
Ref TS53BCModel SFT81_blackline
Identity
- Device Name
- Infrared Ear/ Forehead Thermometer EUDAMED
- Model / Reference
- SFT81_blackline EUDAMEDTS53BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710953424100 EUDAMED
- Basic UDI-DI
- 471095342TCF04TSXN4 EUDAMED
- Direct Marketing DI
- 04710953424100 EUDAMED
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose patient temperature probe, reusable
Infrared Ear/ Forehead Thermometer by Avita Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471095342TCF04TSXN4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- AViTA Corporation
- EUDAMED SRN
- TW-MF-000010455
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 54f91784-1631-4270-8f6e-86a735ae7b8e 61 fields · synced May 23, 2026