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Abintrax
EUDAMEDClass IIa (EU MDR)
Ref 06953825909666Model UFR102 Ref 06953825909659Model U81D
Identity
- Trade Name
- Abintrax EUDAMED
- Device Name
- Infrared Thermometer EUDAMEDWrist Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- UFR102 EUDAMED06953825909666 EUDAMEDU81D EUDAMED06953825909659 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825909666 EUDAMED06953825909659 EUDAMED
- Basic UDI-DI
- B-06953825909666 EUDAMEDB-06953825909659 EUDAMED
- EMDN Code
- V0301010299 DIGITAL THERMOMETERS - OTHER EUDAMEDZ1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Abintrax 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-06953825909666 | 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 88329278-540a-4832-a990-031bc6dfd5a6 61 fields · synced Jul 12, 2026
- EUDAMED 158fd8b8-44b3-43ec-a745-cf0d38fa8796 61 fields · synced May 18, 2026