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ConfiGlu G1 Blood Glucose Meter Set
EUDAMEDClass C (EU MDR)
Ref BGMGS001
by GenBody Inc.
Identity
- Trade Name
- ConfiGlu G1 Blood Glucose Meter Set EUDAMED
- Device Name
- ConfiGlu G1 Blood Glucose Meter Set EUDAMED
- Model / Reference
- BGMGS001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076700833 EUDAMED
- Basic UDI-DI
- 88000767BGMGS001PX EUDAMED
- Direct Marketing DI
- 08800076700826 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
ConfiGlu G1 Blood Glucose Meter Set 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 | 88000767BGMGS001PX | 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 f902fd4c-cfa9-4db2-913c-25ef70bfdd91 61 fields · synced Aug 3, 2026