Identity
- Trade Name
- respons® A1c Analyzer EUDAMEDrespons®A1c Analyzer EUDAMED
- Device Name
- GREENCARE A1c Analyzer EUDAMED
- Model / Reference
- RT-100 EUDAMED963100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806134660651 EUDAMED
- Basic UDI-DI
- B-08806134660651 EUDAMED88061346A1CAKV EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A 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
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
respons® A1c Analyzer by GC Medical Science Corporation — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-08806134660651 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08806134660651 | 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 (2)
- EUDAMED f7894751-8ec5-45f0-baee-127e2201a8c2 61 fields · synced Jun 20, 2026
- EUDAMED 3c3d231c-3d83-4bb9-8fb2-d6da92868d1f 61 fields · synced May 19, 2026