Identity
- Trade Name
- ISE Calibrator 1 EUDAMED
- Device Name
- ISE Calibrator 1 EUDAMED
- Model / Reference
- 984031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153840319 EUDAMED
- Basic UDI-DI
- 6438153BU00135BR EUDAMED
- Direct Marketing DI
- 16438153840319 EUDAMED
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Finland 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 Calibrator 1 by Thermo Fisher Scientific Oy — 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 | 6438153BU00135BR | Class B | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (1)
- EUDAMED fbe2a2c9-60c2-4138-ab2a-1fbb0dd50e04 61 fields · synced Oct 6, 2026