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Mediblink

EUDAMED

Class IIa (EU MDR)

Ref BP126A(M540)Model BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126ARef BP168A(M520)Model BP100A，BP101A，BP103A，BPCB0A-3H，BP163A，BP168A，BP122A，CUFF-A，CUFF-B，CUFF-C

by Shenzhen Combei Technology Co., Ltd.

Identity

Trade Name
Mediblink EUDAMED
Device Name
Blood Pressure Monitors EUDAMED
Blood Pressure Monitor EUDAMED
Model / Reference
BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126A EUDAMED
BP126A(M540) EUDAMED
BP100A，BP101A，BP103A，BPCB0A-3H，BP163A，BP168A，BP122A，CUFF-A，CUFF-B，CUFF-C EUDAMED
BP168A(M520) EUDAMED

Identifiers

Primary DI / UDI-DI
06948158400577 EUDAMED
06948158402687 EUDAMED
Basic UDI-DI
69481584ARM04T8 EUDAMED
69481584ARM02T4 EUDAMED
Direct Marketing DI
06948158400577 EUDAMED
06948158402687 EUDAMED
EMDN Code
Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Slovenia EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Mediblink by Shenzhen Combei Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Shenzhen Combei Technology Co., Ltd.
EUDAMED SRN
CN-MF-000016047
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED 6198e111-1dbd-4a2e-be39-65d34ad60dcf 61 fields · synced Oct 6, 2026
  • EUDAMED e2485fde-2067-4d14-9987-b5812298a826 61 fields · synced May 18, 2026