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HbA2 & HbF & HbA1c Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref GHDBZRef HBBZGH
Identity
- Trade Name
- HbA2 & HbF & HbA1c Calibrator EUDAMEDHbA1c Calibrator EUDAMED
- Device Name
- HbA2 & HbF & HbA1c Calibrator EUDAMEDHbA1c Calibrator EUDAMED
- Model / Reference
- GHDBZ EUDAMEDHBBZGH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977125152447 EUDAMED06971225939069 EUDAMED
- Basic UDI-DI
- B-06977125152447 EUDAMEDB-06971225939069 EUDAMED
- EMDN Code
- W0103010507 WHOLE BLOOD CALIBRATORS EUDAMEDW0101050302 CALIBRATORS SINGLE COMPONENT (CC) 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 Calibrator 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-06977125152447 | 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 400921fb-7091-494f-978b-7b1cd0fe7ca9 61 fields · synced Jul 24, 2026
- EUDAMED fe9adb88-fb6a-430c-8818-2dc147442ee5 61 fields · synced May 17, 2026