Identity
- Trade Name
- Zyskaj Zdrowie EUDAMED
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- UFR102 EUDAMED06953825909475 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825909475 EUDAMED
- Basic UDI-DI
- B-06953825909475 EUDAMED
- EMDN Code
- V0301010299 DIGITAL THERMOMETERS - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Zyskaj Zdrowie by Shenzhen Urion Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06953825909475 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Urion Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018740
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 2fce2bb6-719e-48c3-a44e-48b09f7c997e 61 fields · synced Jul 15, 2026