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AUTODXTM HbA1c Test
EUDAMEDClass IVD General (EU MDR)
Ref E1C100, E1C150Model Dx.HbA1c
by DxGen Corp.
Identity
- Trade Name
- AUTODXTM HbA1c Test EUDAMED
- Model / Reference
- Dx.HbA1c EUDAMEDE1C100, E1C150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800031900094 EUDAMED
- Basic UDI-DI
- B-08800031900094 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland 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
AUTODXTM HbA1c Test by DxGen Corp. — 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-08800031900094 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DxGen Corp.
- EUDAMED SRN
- KR-MF-000030876
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED b58ab141-fca4-4403-a8c0-42f5336dd86e 61 fields · synced Jul 20, 2026
- EUDAMED b58ab141-fca4-4403-a8c0-42f5336dd86e-1 61 fields · synced Jun 9, 2026