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Wrist Digital Blood Pressure Monitor

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref REFModel BSX312Model BSX322Model BSX313

by Shenzhen Bsx Technology Electronics Co., Ltd.

Identity

Device Name
Wrist Digital Blood Pressure Monitor EUDAMED
Model / Reference
BSX312 EUDAMED
REF EUDAMED
BSX322 EUDAMED
BSX313 EUDAMED

Identifiers

Primary DI / UDI-DI
06920485308108 EUDAMED
06920485307606 EUDAMED
06920485307828 EUDAMED
Basic UDI-DI
B-06920485308108 EUDAMED
B-06920485307606 EUDAMED
B-06920485307828 EUDAMED
EMDN Code
Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Z1203020408 PULSE OXIMETERS EUDAMED
Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES 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 — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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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 (4)

  • EUDAMED 868b84c7-a27a-423d-a664-4cfe39ae8937 61 fields · synced Jul 20, 2026
  • EUDAMED de9267e4-1901-4e30-9fe2-e53b30890158 61 fields · synced May 19, 2026
  • EUDAMED d175e8a8-9d13-4003-9a70-a7bfe4a08c0d 61 fields · synced May 19, 2026
  • FDA 510(k) K241578 1 fields · synced May 19, 2026