Identity
- Trade Name
- ISE High Calibrator EUDAMED
- Device Name
- ISE High Calibrator EUDAMED
- Model / Reference
- 0018469300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426950021766 EUDAMED
- Basic UDI-DI
- 84269500217665Q EUDAMED
- Direct Marketing DI
- 08426950021766 EUDAMED
- EMDN Code
- W0101050303 AQUEOUS STANDARDS (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
No
EUDAMED
ISE High Calibrator by Instrumentation Laboratory SpA — Class B — 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 | 84269500217665Q | Class B | Active |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory SpA
- EUDAMED SRN
- IT-MF-000009277
Sources (1)
- EUDAMED 7ddc9093-6537-4249-b06f-0a5d75249836 61 fields · synced Jun 18, 2026