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Wearable ECG Sensor
EUDAMEDClass I (EU MDR)
Ref PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F
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
Identifiers
- Primary DI / UDI-DI
- 06970912081098 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
- Italy 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697091208PS2G | Class I | Active |
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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 (2)
- EUDAMED a712f21c-1b5f-4821-ae68-a8d565a8359a 61 fields · synced Oct 6, 2026
- EUDAMED a712f21c-1b5f-4821-ae68-a8d565a8359a-1 61 fields · synced Jun 10, 2026