Identity
- Trade Name
- BSX EUDAMED
- Device Name
- Wrist Digital Blood Pressure Monitor EUDAMEDArm Type Electronic Blood Pressure Monitor EUDAMED
- Model / Reference
- BSX312 EUDAMEDREF EUDAMEDBSX525 EUDAMEDBSX325 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920485306630 EUDAMED06920485306111 EUDAMED06920485306128 EUDAMED
- Basic UDI-DI
- B-06920485306630 EUDAMEDB-06920485306111 EUDAMEDB-06920485306128 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMEDZ1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Bsx by Shenzhen BSX Technology Electronics 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-06920485306630 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Bsx Technology Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000015965
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 0c66e6db-ebb3-4fd0-9fac-c5a29b05740e 61 fields · synced Jul 9, 2026
- EUDAMED dcb2141e-9a2a-4f8d-8d79-9a563bd73747 61 fields · synced May 18, 2026
- EUDAMED c8316b58-4036-409d-8b54-15fd9eccfc28 61 fields · synced Jun 20, 2026