Identity
- Trade Name
- QDx A1c Advance EUDAMED
- Device Name
- GREENCARE A1c Analyzer EUDAMEDQDx A1c Advance EUDAMED
- Model / Reference
- RT-100 EUDAMEDRT100M10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806134660620 EUDAMED
- Basic UDI-DI
- 88061346A1CAKV EUDAMEDB-08806134660620 EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
QDx A1c Advance by GC Medical Science Corporation — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 88061346A1CAKV | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 88061346A1CAKV | Class A | 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 b662c007-c3a3-4157-a1b3-4833bbebe13f 61 fields · synced Jul 9, 2026
- EUDAMED 444bcf71-0042-456b-9464-faa653b03f00 61 fields · synced May 19, 2026