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HbA2 & HbF & HbA1c Control
EUDAMEDClass IVD General (EU MDR)
Ref GHDDM1Ref GHDDM2
Identity
- Trade Name
- HbA2 & HbF & HbA1c Control EUDAMED
- Device Name
- HbA2 & HbF & HbA1c Control EUDAMED
- Model / Reference
- GHDDM1 EUDAMEDGHDDM2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977125152423 EUDAMED06977125152430 EUDAMED
- Basic UDI-DI
- B-06977125152423 EUDAMEDB-06977125152430 EUDAMED
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HbA2 & HbF & HbA1c Control 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-06977125152423 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Goldsite Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000001353
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 4df15f42-4503-4bc0-84d5-55b75c9c10e7 61 fields · synced Jul 12, 2026
- EUDAMED cfba2298-1c06-420b-afd5-8232087edc30 61 fields · synced May 18, 2026