Identity
- Device Name
- infrared thermomter EUDAMED
- Model / Reference
- EF EUDAMEDEF-100A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949395010116 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 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 (1)
- EUDAMED ed6ca522-6aea-45b5-9161-9d71b116c45d 61 fields · synced May 23, 2026