Identity
- Trade Name
- Amylase (IFCC) EUDAMED
- Device Name
- Amylase (IFCC) EUDAMED
- Model / Reference
- 981950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153005220 EUDAMED
- Basic UDI-DI
- 6438153BU00061BM EUDAMED
- Direct Marketing DI
- 16438153005220 EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL EUDAMED
Classification
- Device Class
- Class C 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
Amylase (IFCC) by Thermo Fisher Scientific Oy — Class C — 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 | 6438153BU00061BM | Class C | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (1)
- EUDAMED 31516195-b708-4f2f-8c9a-58056e8b5171 61 fields · synced Jul 11, 2026