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GCare Glucose
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref GBP110S10Model GBP-110Ref 0639C10
Identity
- Trade Name
- GCare Glucose EUDAMEDGCare Glucose Control Solution EUDAMED
- Device Name
- GCare Glucose EUDAMEDGCare Glucose Control Solution EUDAMED
- Model / Reference
- GBP-110 EUDAMEDGBP110S10 EUDAMED0639C10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806134663713 EUDAMED08806134663911 EUDAMED
- Basic UDI-DI
- B-08806134663713 EUDAMEDB-08806134663911 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
GCare Glucose by GC Medical Science Corporation — 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-08806134663713 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- GC Medical Science Corporation
- EUDAMED SRN
- KR-MF-000015840
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 47d1ab43-d204-483a-a064-50f8a41b732b 61 fields · synced Sep 18, 2026
- EUDAMED 548e1e68-1dd4-4663-a9a9-57c52f58a738 61 fields · synced May 18, 2026