Identity
- Trade Name
- sCal EUDAMED
- Device Name
- sCal EUDAMED
- Model / Reference
- 981831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153818318 EUDAMED
- Basic UDI-DI
- 6438153BU00055BS EUDAMEDB-16438153818318 EUDAMED
- Direct Marketing DI
- 16438153818318 EUDAMED
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMEDW0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
sCal by Thermo Fisher Scientific Oy — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6438153BU00055BS | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00055BS | Class C | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED 8e4fe192-4769-4d9f-9f59-eb7e35247ffd 61 fields · synced Oct 6, 2026
- EUDAMED c1b2c33d-7bff-4543-b63a-3955e6a24fcd 61 fields · synced Jul 10, 2026