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Sangool
EUDAMEDClass IIa (EU MDR)
Ref 06953825910532Model U63HRef 06953825908942Model UFR105
Identity
- Trade Name
- SANGOOL EUDAMED
- Device Name
- Wrist Electronic Blood Pressure Monitor EUDAMEDInfrared Thermometer EUDAMED
- Model / Reference
- U63H EUDAMED06953825910532 EUDAMEDUFR105 EUDAMED06953825908942 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825910532 EUDAMED06953825908942 EUDAMED
- Basic UDI-DI
- B-06953825910532 EUDAMEDB-06953825908942 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMEDV0301010299 DIGITAL THERMOMETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
Sangool 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-06953825910532 | 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 (2)
- EUDAMED c5f64b38-3e48-4e50-93c5-be1887a18d13 61 fields · synced Jul 15, 2026
- EUDAMED 588853ac-63ef-4c2d-9d46-58d4689496e6 61 fields · synced May 17, 2026