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BKM-02 Blood Ketone Monitoring System
EUDAMEDClass A (EU MDR)
Ref BT0000801Model BKM-02
Identity
- Trade Name
- BKM-02 Blood Ketone Monitoring System EUDAMED
- Device Name
- BKM-02 Blood Ketone Monitoring System EUDAMED
- Model / Reference
- BKM-02 EUDAMEDBT0000801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260214037 EUDAMED
- Basic UDI-DI
- 69332602IT01000109S EUDAMED
- EMDN Code
- W02020699 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMEDEUDAMED
BKM-02 Blood Ketone Monitoring System by Xiamen Biotime Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69332602IT01000109S | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED 41cd607e-e81e-4a0d-afe8-f1415de4fef4 61 fields · synced Oct 8, 2026
- EUDAMED fded9e7c-e75e-48e5-a08e-9d2506ed40fd 61 fields · synced Jul 12, 2026
- EUDAMED 2471ca26-5cf0-4ff6-bce1-7e6bcfccffbd 61 fields · synced Oct 8, 2026