Identity
- Trade Name
- Calcium EUDAMED
- Device Name
- Calcium EUDAMED
- Model / Reference
- 981953 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153007316 EUDAMED
- Basic UDI-DI
- B-16438153007316 EUDAMED6438153BU00127BS EUDAMED
- Direct Marketing DI
- 16438153007316 EUDAMED
- EMDN Code
- W01010303 CALCIUM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass 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
Calcium 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-16438153007316 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-16438153007316 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED 70502920-1a44-45d0-b15e-3fc189d8502e 61 fields · synced Jun 9, 2026
- EUDAMED a276837d-8fe9-4570-a87a-22dc81868753 61 fields · synced May 17, 2026