Identity
- Trade Name
- Serachem HbA1c EUDAMED
- Device Name
- HbA1c EUDAMED
- Model / Reference
- 0018167500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426951410835 EUDAMED
- Basic UDI-DI
- 84307930553384W EUDAMED
- Direct Marketing DI
- 08426951410835 EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Serachem HbA1c by Instrumentation Laboratory SpA — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 84307930553384W | Class C | Active |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory SpA
- EUDAMED SRN
- IT-MF-000009277
Sources (1)
- EUDAMED c390223f-03d7-4424-8cd5-e119dde84b1c 61 fields · synced Jun 19, 2026