Identity
- Trade Name
- HbA1c Assay Kit (HPLC) EUDAMED
- Device Name
- HbA1c Assay Kit (HPLC) EUDAMED
- Model / Reference
- GHB100 EUDAMEDGHB200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977125152386 EUDAMED06977125152393 EUDAMED
- Basic UDI-DI
- B-06977125152386 EUDAMEDB-06977125152393 EUDAMED
- EMDN Code
- W0102060109 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HbA1c Assay Kit (HPLC) by Goldsite Diagnostics Inc. — 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-06977125152386 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Goldsite Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000001353
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED bf82fcc9-db43-45a0-a2a8-64bffc726ee4 61 fields · synced Jul 9, 2026
- EUDAMED df48cb59-7084-4827-a5d0-f86b3e7ac3e2 61 fields · synced May 18, 2026