Identity
- Trade Name
- Performa A1c Analyzer EUDAMED
- Device Name
- GREENCARE A1c Analyzer EUDAMED
- Model / Reference
- RT-100 EUDAMEDRT100M12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806134660668 EUDAMED
- Basic UDI-DI
- 88061346A1CAKV EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania 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
Performa A1c Analyzer by GC Medical Science Corporation — Class A — 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 | 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 (1)
- EUDAMED 2d22f94d-122d-435f-8f15-739f03e1ca17 61 fields · synced Jun 18, 2026