Infrared Ear Thermometer
by Radiant Innovation Inc. Taiwan EUDAMED
Ref THP59J(U) EMDN V0301010202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberTW24/00000261 | Date10 Jul 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- TW24/00000261 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 10 Jul 2024
- Expires
- 26 Mar 2029
- Reason
- Change approved
Specification
- Device Name
- Infrared Ear Thermometer
- Model / Reference
- THP59J(U)
- Primary DI / UDI-DI
- 04710810451560
- Basic UDI-DI
- 471081045IETE8
- EMDN Code
- V0301010202 Non-contact digital thermometers
- Device Class
- Class IIa
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- TW-MF-000007935
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Radiant Innovation Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 7834aa21-de25-418c-9fe8-8f70118161b0