Identity
- Trade Name
- SpeciTrol EUDAMED
- Device Name
- Specitrol EUDAMED
- Model / Reference
- 981250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153812507 EUDAMED
- Basic UDI-DI
- B-16438153812507 EUDAMED6438153BU00169CA EUDAMED
- Direct Marketing DI
- 16438153812507 EUDAMED
- EMDN Code
- W0101050202 LIPID CONTROLS EUDAMEDW01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Specitrol by Thermo Fisher Scientific Oy — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-16438153812507 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-16438153812507 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED 1e3258bf-5f8a-444b-b619-b8314e02c418 61 fields · synced Oct 5, 2026
- EUDAMED 03172bbf-e11b-49b9-9688-f3f5f22d9af2 61 fields · synced May 19, 2026