Identity
- Trade Name
- PocketChem A1c Advanced EUDAMED
- Device Name
- GREENCARE A1c Analyzer EUDAMED
- Model / Reference
- RT-100 EUDAMED107032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806134660644 EUDAMED
- Basic UDI-DI
- 88061346A1CAKV EUDAMEDB-08806134660644 EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General 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
PocketChem A1c Advanced 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GC Medical Science Corporation
- EUDAMED SRN
- KR-MF-000015840
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED ff06fa7f-21fd-41e8-92a5-725827bba440 61 fields · synced Jun 19, 2026
- EUDAMED 8a4d6af5-a040-4757-b0d9-71852fb1bf11 61 fields · synced May 19, 2026