Identity
- Device Name
- DoA Calibration set E EUDAMED
- Model / Reference
- 981736 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153817366 EUDAMED
- Basic UDI-DI
- B-16438153817366 EUDAMED
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General 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
DoA Calibration set E by Thermo Fisher Scientific Oy — 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-16438153817366 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (1)
- EUDAMED 72b89c9a-a9d3-4d2f-9d55-03d22d47aa3c 61 fields · synced Oct 6, 2026