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Wearable ECG Sensor

EUDAMED

Class I (EU MDR)

Ref PS-B3EModel PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3FRef PS-B3FRef PS-B3DRef PS-B3C

by Biomedical Instruments Co., Ltd.

Identity

Trade Name
Wearable ECG Sensor EUDAMED
Device Name
Wearable ECG Sensor EUDAMED
Model / Reference
PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F EUDAMED
PS-B3E EUDAMED
PS-B3F EUDAMED
PS-B3D EUDAMED
PS-B3C EUDAMED

Identifiers

Primary DI / UDI-DI
06970912081319 EUDAMED
06970912081326 EUDAMED
06970912081302 EUDAMED
06970912081111 EUDAMED
Basic UDI-DI
697091208PS2G EUDAMED
EMDN Code
Z12050485 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Wearable ECG Sensor by Biomedical Instruments Co., Ltd. — Class I — 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
Biomedical Instruments Co., Ltd.
EUDAMED SRN
CN-MF-000016483
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED 012e680f-1be7-4012-9606-a1b0b2eff961 61 fields · synced Oct 6, 2026
  • EUDAMED 37743287-079a-4cdd-8109-cd7becd2c4c7 61 fields · synced May 17, 2026
  • EUDAMED 4cf6ce29-18cd-4973-8dcb-a84f771a87d2 61 fields · synced May 18, 2026
  • EUDAMED 3fc40e98-1274-4b25-bb5c-174f371daf23 61 fields · synced May 19, 2026