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Bsxin

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref REFModel BSX579

by Shenzhen Bsx Technology Electronics Co., Ltd.

Identity

Trade Name
BSXIN EUDAMED
BOTHEALTH FDA UDI
Generic Name
Patient monitoring system module, blood pressure, noninvasive FDA UDI
Device Name
Arm Type Electronic Blood Pressure Monitor EUDAMED
Model / Reference
BSX579 EUDAMEDFDA UDI
REF EUDAMED

Identifiers

Primary DI / UDI-DI
06920485305794 EUDAMEDFDA UDI
Basic UDI-DI
B-06920485305794 EUDAMED
510(k) Number
K183058 FDA UDI
FDA Product Code
DXN FDA UDI
EMDN Code
Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
GMDN Term
Patient monitoring system module, blood pressure, noninvasive FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Bsxin by Shenzhen Bsx Technology Electronics Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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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 (2)

  • EUDAMED 1f4ee631-5b9b-41de-ba38-309486fc16d7 61 fields · synced Jul 23, 2026
  • FDA UDI 07acffcd-544b-4c6f-a990-cbb6b38802bc 33 fields · synced May 22, 2026