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4FIZJO Infrared Thermometer
EUDAMEDClass IIa (EU MDR)
Ref AET-R1B1Ref AET-R612A
Identity
- Trade Name
- 4FIZJO Infrared Thermometer EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- AET-R1B1 EUDAMEDAET-R612A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953775660754 EUDAMED06953775660761 EUDAMED
- Basic UDI-DI
- 69537756R1B1VP EUDAMED69537756R61XXC EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMEDV0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
4FIZJO Infrared Thermometer by Alicn Medical Shenzhen, Inc — 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 | 69537756R1B1VP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alicn Medical Shenzhen, Inc
- EUDAMED SRN
- CN-MF-000001920
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 1b40bd1e-fc59-4077-a887-98b0a9cc119b 61 fields · synced Jul 19, 2026
- EUDAMED caac79fc-0fed-46d5-a7b2-d4ccfaef8952 61 fields · synced May 19, 2026