Identity
- Trade Name
- ABP-03 EUDAMED
- Device Name
- Wearable Ambulatory Blood Pressure Monitor EUDAMED
- Model / Reference
- ABP-03 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06975164324320TT EUDAMED
- Basic UDI-DI
- B-06975164324320TT EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS 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
Abp-03 by Shenzhen Hingmed Medical Instrument 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-06975164324320TT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Hingmed Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000004838
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED b07970a7-6c84-4eac-a63f-c3055ac276f6 61 fields · synced Jul 8, 2026