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GREENCARE A1c Hemoglobin A1c Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref RT100S10Model GREENCARE A1c Hemoglobin A1c Test Kit
Identity
- Trade Name
- GREENCARE A1c Hemoglobin A1c Test Kit EUDAMED
- Device Name
- GREENCARE A1c Hemoglobin A1c Test Kit EUDAMED
- Model / Reference
- GREENCARE A1c Hemoglobin A1c Test Kit EUDAMEDRT100S10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KR-MF-000015840BS EUDAMED
- Basic UDI-DI
- B-KR-MF-000015840BS EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
GREENCARE A1c Hemoglobin A1c Test Kit by GC Medical Science Corporation — Class IVD General — 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-KR-MF-000015840BS | Class IVD General | 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 (1)
- EUDAMED a0db3ba6-0cb1-41f9-8078-e36981c5593f 61 fields · synced Jun 18, 2026