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ConfiGlu G1 Glucose Control solution 3
EUDAMEDClass C (EU MDR)
Ref BGC003
by GenBody Inc.
Identity
- Trade Name
- ConfiGlu G1 Glucose Control solution 3 EUDAMED
- Device Name
- ConfiGlu G1 Glucose Control Solution EUDAMED
- Model / Reference
- BGC003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076701328 EUDAMED
- Basic UDI-DI
- 88000767BGC0038K EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
ConfiGlu G1 Glucose Control solution 3 by Genbody Inc. — Class C — 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 | 88000767BGC0038K | Class C | Active |
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Manufacturer
- Manufacturer
- GenBody Inc.
- EUDAMED SRN
- KR-MF-000043626
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 126b41b2-55fc-40a2-ae7c-9fabca0f6449 61 fields · synced Jul 10, 2026