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Blood Ketone Meters
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref System（Model T-1）：114010011Model Meter T-1
Identity
- Device Name
- Blood Ketone Meters EUDAMED
- Model / Reference
- Meter T-1 EUDAMEDSystem（Model T-1）：114010011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06914329008842 EUDAMED
- Basic UDI-DI
- B-06914329008842 EUDAMED
- EMDN Code
- W0201069092 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Blood Ketone Meters 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06914329008842 | 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 f81ad2ce-5a58-47a6-9a1d-74506dacb137 61 fields · synced Jun 18, 2026