Identity
- Trade Name
- HDL-Cholesterol EUDAMED
- Device Name
- HDL-Cholesterol EUDAMED
- Model / Reference
- 981955 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153007330 EUDAMED
- Basic UDI-DI
- 6438153BU00133BM EUDAMEDB-16438153007330 EUDAMED
- Direct Marketing DI
- 16438153007330 EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass 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
New Device
No
EUDAMED
HDL-Cholesterol by Thermo Fisher Scientific Oy — Class B — 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 | 6438153BU00133BM | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00133BM | Class B | 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 f10cdb24-4467-49d4-b3cf-ca4eb43101ea 61 fields · synced Jun 19, 2026
- EUDAMED 734248fb-14eb-4938-80d6-3fe53bc1281f 61 fields · synced May 17, 2026