← Back to catalogue
Wearable ECG Sensor
EUDAMEDClass I (EU MDR)
Ref PS-B3BModel 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 EUDAMEDPS-B3B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912081104 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697091208PS2G | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomedical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000016483
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e6ef154e-aec9-4e26-888c-ff9c2b8d7b67 61 fields · synced Jun 19, 2026