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Infrared Ear/ Forehead Thermometer
EUDAMEDClass IIa (EU MDR)
Ref TS53BCModel SFT81_blacklineRef TS53Ref TS29Model 00009903000000Ref TS15Ref SFT79Ref STF79/TS53Ref SFT79/TS53
Identity
- Trade Name
- Infrared Ear/ Forehead Thermometer EUDAMED
- Device Name
- Infrared Ear/ Forehead Thermometer EUDAMED
- Model / Reference
- SFT81_blackline EUDAMEDTS53BC EUDAMEDTS53 EUDAMED00009903000000 EUDAMEDTS29 EUDAMEDTS15 EUDAMEDSFT79 EUDAMEDSTF79/TS53 EUDAMEDSFT79/TS53 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710953424131 EUDAMED04710953425176 EUDAMED04710953422410 EUDAMED04710953425145 EUDAMED03770011742745 EUDAMED04710953425091 EUDAMED04710953424148 EUDAMED04710953424728 EUDAMED04710953425152 EUDAMED04710953424162 EUDAMED04710953424506 EUDAMED04710953424490 EUDAMED04710953425169 EUDAMED04710953424711 EUDAMED04710953422489 EUDAMED04710953425107 EUDAMED04710953424124 EUDAMED
- Basic UDI-DI
- 471095342TCF04TSXN4 EUDAMEDB-04710953422410 EUDAMEDB-04710953422489 EUDAMED
- Direct Marketing DI
- 04710953424131 EUDAMED04710953425176 EUDAMED04710953425145 EUDAMED03770011742745 EUDAMED04710953425091 EUDAMED04710953424148 EUDAMED04710953425152 EUDAMED04710953424162 EUDAMED04710953424506 EUDAMED04710953424490 EUDAMED04710953425169 EUDAMED04710953425107 EUDAMED04710953424124 EUDAMED
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMEDV0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMEDV03010201,Z1203020501 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMEDGreece EUDAMEDGermany EUDAMEDAustria EUDAMEDFrance EUDAMEDBelgium EUDAMEDSpain EUDAMEDLatvia EUDAMEDDenmark EUDAMEDCyprus EUDAMEDPortugal EUDAMEDIreland 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 — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 471095342TCF04TSXN4 | Class IIa | Active |
| 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 (17)
- EUDAMED b4196cef-8898-4f59-95af-80b7cb008a50 61 fields · synced Oct 6, 2026
- EUDAMED 9b5fb125-8ff8-4b92-a444-51ee21056086 61 fields · synced May 16, 2026
- EUDAMED fdc5203d-9e07-400e-85b8-3ffa261b2674 61 fields · synced May 16, 2026
- EUDAMED f71ce7ba-1cbd-4396-b1ee-f33c4907c101 61 fields · synced May 17, 2026
- EUDAMED c50423db-51f3-4c6c-ab90-77d0ad238ec9 61 fields · synced May 17, 2026
- EUDAMED 1a255f80-4bb0-4c57-bcc2-addf05131615 61 fields · synced May 17, 2026
- EUDAMED 0d763c5c-b7b8-4637-8cd8-38c2a3c344fc 61 fields · synced Jul 9, 2026
- EUDAMED 68d21961-07da-4613-81d3-813acc6c5149 61 fields · synced Jul 11, 2026
- EUDAMED f6c6de3b-3c9b-4cb3-bb2f-fc453599565c 61 fields · synced Jul 13, 2026
- EUDAMED a3dca7f2-2f31-4491-9f7b-feaf6a964ad1 61 fields · synced Jul 13, 2026
- EUDAMED db82fffb-4447-441b-94bd-35d9d8166f9e 61 fields · synced Jul 14, 2026
- EUDAMED 993d7fef-2a0c-4103-b7b3-2e2a36d00a1a 61 fields · synced Jul 24, 2026
- EUDAMED 46951fd2-7042-4069-9dd1-dd75cebd8bc4 61 fields · synced Jul 26, 2026
- EUDAMED 433b4563-9347-4a35-a57c-65cbcc03d2c9 61 fields · synced Jul 28, 2026
- EUDAMED e804e105-7f93-4ccc-abf9-cff6855c870a 61 fields · synced Jul 29, 2026
- EUDAMED 7b81f306-9958-49a5-a0b7-4748f603b2c3 61 fields · synced Aug 2, 2026
- EUDAMED 8472d0c1-5fb3-4fb2-a21b-98322dc67c25 61 fields · synced Oct 6, 2026