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HbA1c Kit (Reagents for STAT LAB T Analyzer & Auto Chemistry Analyzer)
EUDAMEDClass IVD General (EU MDR)
Ref 401 001Ref 401 002
Identity
- Trade Name
- HbA1c Kit (Reagents for STAT LAB T Analyzer & Auto Chemistry Analyzer) EUDAMEDHbA1c EUDAMED
- Device Name
- HbA1c plus (Reagents for STAT LAB T Analyzer & Auto Chemistry Analyzer) EUDAMEDHbA1c EUDAMED
- Model / Reference
- 401 001 EUDAMED401 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041047256 EUDAMED62230041047324 EUDAMED
- Basic UDI-DI
- B-62230041047256 EUDAMEDB-62230041047324 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 Kit (Reagents for STAT LAB T Analyzer & Auto Chemistry Analyzer) by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDD…
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-62230041047256 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 596d09b2-8853-41d1-bfc1-73c94d254ed2 61 fields · synced Oct 6, 2026
- EUDAMED 61b9e77a-e284-4e11-b441-d5d0ffa76f7e 61 fields · synced May 18, 2026