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Blood Glucose Meter

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref System（5D-1）：113010013、System（5D-2）：113020010、System（5D-3）：113030014、System（5D-6）：113040014、System（5D-8B）：113070018Model Model 5D-1、 Model 5D-2、Model 5D-3、Model 5D-6、 Model 5D-7、 Model 5D-8BRef 113010012、113020009、113030013、113040013、113050009、113070017

by Beijing Yicheng Bioelectronics Technology Co., Ltd.

Identity

Device Name
Blood Glucose Meter EUDAMED
Model / Reference
Model 5D-1、 Model 5D-2、Model 5D-3、Model 5D-6、 Model 5D-7、 Model 5D-8B EUDAMED
System（5D-1）：113010013、System（5D-2）：113020010、System（5D-3）：113030014、System（5D-6）：113040014、System（5D-8B）：113070018 EUDAMED
113010012、113020009、113030013、113040013、113050009、113070017 EUDAMED

Identifiers

Primary DI / UDI-DI
06914329008729 EUDAMED
06914329008668 EUDAMED
Basic UDI-DI
B-06914329008729 EUDAMED
B-06914329008668 EUDAMED
EMDN Code
W0201060102 BLOOD GLUCOSE METERS EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMEDEUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

Blood Glucose Meter by Beijing Yicheng Bioelectronics Technology Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Beijing Yicheng Bioelectronics Technology Co., Ltd.
EUDAMED SRN
CN-MF-000033130
Authorised Representative
Caretechion GmbH DE-AR-000005946

Sources (2)

  • EUDAMED 5d0e92ed-243f-4fa6-9120-b6be404f4542 61 fields · synced Jul 22, 2026
  • EUDAMED 9850cd06-cfdf-4409-b4c9-33380ab85bc3 61 fields · synced May 17, 2026