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Wrist Digital Blood Pressure Monitor
EUDAMEDClass IIa (EU MDR)
Ref REFModel BSX313
Identity
- Device Name
- Wrist Digital Blood Pressure Monitor EUDAMED
- Model / Reference
- BSX313 EUDAMEDREF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920485308115 EUDAMED
- Basic UDI-DI
- B-06920485308115 EUDAMED
- EMDN Code
- Z1203020302 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
Wrist Digital Blood Pressure Monitor 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-06920485308115 | 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 (1)
- EUDAMED 3ec6c9d0-9788-4b25-99c3-39b994bd17fe 61 fields · synced Jun 19, 2026