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infrared thermomter
EUDAMEDClass IIa (EU MDR)
Ref EF-100BModel EFRef FT-100ARef FT-100BRef FT-100C
Identity
- Device Name
- infrared thermomter EUDAMED
- Model / Reference
- EF EUDAMEDEF-100B EUDAMEDFT-100A EUDAMEDFT-100B EUDAMEDFT-100C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949395010123 EUDAMED06949395010147 EUDAMED06949395010154 EUDAMED06949395010161 EUDAMED
- Basic UDI-DI
- 69493950GF-EFS9 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDTürkiye EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
infrared thermomter by Hangzhou Universal Electronic Co., Ltd. — 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 | 69493950GF-EFS9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Universal Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000017192
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (4)
- EUDAMED 86a49c93-2f8f-488c-a215-d4a2f59164b1 61 fields · synced Jul 8, 2026
- EUDAMED d015d9a6-0a71-4d06-879f-4cb737865d12 61 fields · synced May 16, 2026
- EUDAMED a440ae7f-564e-4060-888f-94d78b307f2f 61 fields · synced May 17, 2026
- EUDAMED 686c2bc4-600f-43a8-9671-7bb9396a0840 61 fields · synced May 18, 2026