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ric Acid Test Strips 、Blood Glucose Test Strips、 Blood Glucose and Uric Acid Me…
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref System（5DU-1）：113080006Model Model 5DU-1、UB-Ⅰ、5D、5D into the top form
Identity
- Device Name
- ric Acid Test Strips 、Blood Glucose Test Strips、 Blood Glucose and Uric Acid Meters EUDAMED
- Model / Reference
- Model 5DU-1、UB-Ⅰ、5D、5D into the top form EUDAMEDSystem（5DU-1）：113080006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06914329008613 EUDAMED
- Basic UDI-DI
- B-06914329008613 EUDAMED
- EMDN Code
- W020106019092 VARIOUS DIABETES MONITORING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE 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
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
ric Acid Test Strips 、Blood Glucose Test Strips、 Blood Glucose and Uric Acid Me… by Beijing Yicheng Bioelectronics Technology Co., Ltd. — Class IVD devices…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06914329008613 | Class IVD devices for self-testing | Active |
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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 (1)
- EUDAMED e0cd3072-9e23-4306-891a-a8df4018db8c 61 fields · synced Jun 19, 2026