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Blood Glucose Monitoring system
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref BG-707Ref BG-201
Identity
- Trade Name
- Blood Glucose Monitoring system EUDAMEDSEJOY Blood Glucose Monitoring System EUDAMED
- Device Name
- Blood Glucose Meter EUDAMEDBlood Glucose Monitoring System EUDAMED
- Model / Reference
- BG-707 EUDAMEDBG-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663988001 EUDAMED06939663915571 EUDAMED
- Basic UDI-DI
- B-06939663988001 EUDAMEDB-06939663915571 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Blood Glucose Monitoring system by Sejoy Biomedical Co., Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06939663988001 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b1735cca-b118-4930-8e97-223bb32431f0 61 fields · synced Oct 6, 2026
- EUDAMED 16cfa262-37b8-48d0-a6a7-0d40aab70a32 61 fields · synced May 18, 2026