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Snapshot 2026-10-10 · Link to EUDAMED

Holter System

UDI-DI 06970912081234Basic UDI-DI 697091208AECGGJ

Class IIa · MDR · Biomedical Instruments Co., Ltd.

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Identification

Model: BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C
EMDN: Z12050403
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: Yes
Reusable surgical: Yes

Certificates

No certificate found.

Snapshot 2026-10-10 · Link to EUDAMED

Manufacturer

Biomedical Instruments Co., Ltd.

SRN CN-MF-000016483

CN · Shenzhen

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/holter-system-1234 · UDI page: /udi/06970912081234

All devices from Biomedical Instruments Co., Ltd.

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