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Pc Ecg
EUDAMEDClass IIa (EU MDR)
Ref BI 12CModel BI 12A, BI 12C, BI 12DRef G5106Model TeleECG-12CRef BI 12ARef G5108Model TeleECG-12A
Identity
- Trade Name
- PC ECG EUDAMED
- Device Name
- PC ECG EUDAMED
- Model / Reference
- BI 12A, BI 12C, BI 12D EUDAMEDBI 12C EUDAMEDTeleECG-12C EUDAMEDG5106 EUDAMEDBI 12A EUDAMEDTeleECG-12A EUDAMEDG5108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970912080442 EUDAMED06970912080336 EUDAMED06970912080435 EUDAMED06970912080312 EUDAMED
- Basic UDI-DI
- 697091208PCECGJF EUDAMEDB-06970912080336 EUDAMEDB-06970912080312 EUDAMED
- Direct Marketing DI
- 06970912080442 EUDAMED06970912080435 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPortugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pc Ecg by Biomedical Instruments Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697091208PCECGJF | Class IIa | Active |
| 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 (4)
- EUDAMED a3a0698e-a908-4c1e-9ac7-0d51b8ee83f1 61 fields · synced Oct 6, 2026
- EUDAMED ff6c3b3c-10d2-4817-a654-738e7ea28ab7 61 fields · synced May 18, 2026
- EUDAMED d9d7aa96-d21f-4b5a-8443-f42c95092476 61 fields · synced May 18, 2026
- EUDAMED 25f83ad4-c25a-4785-ae19-fa9fd036f168 61 fields · synced May 19, 2026