Identity
- Trade Name
- PC ECG EUDAMED
- Device Name
- PC ECG EUDAMED
- Model / Reference
- BI 12A, BI 12C, BI 12D EUDAMEDBI 12D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912080466 EUDAMED
- Basic UDI-DI
- 697091208PCECGJF EUDAMED
- Direct Marketing DI
- 06970912080466 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Electrocardiographic lead set, reusable
Pc Ecg by Biomedical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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 | 697091208PCECGJF | Class IIa | 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 (1)
- EUDAMED 92a60254-74f4-4373-bf07-62d18399b4b9 61 fields · synced Jun 17, 2026