Identity
- Trade Name
- Apolipoprotein B EUDAMED
- Device Name
- Apolipoprotein B EUDAMED
- Model / Reference
- 981930 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153819308 EUDAMED
- Basic UDI-DI
- 6438153BU00174C3 EUDAMEDB-16438153819308 EUDAMED
- Direct Marketing DI
- 16438153819308 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B 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
Category: Apolipoprotein B (Apo B) IVD, reagent
Apolipoprotein B by Thermo Fisher Scientific Oy — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Lipoprotein (a) — Diagam S.A. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Apolipoprotein B Reagent (ApoB 2 x 100) — Beckman Coulter, Inc. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method) — MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
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 | 6438153BU00174C3 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00174C3 | 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 aab9eb00-0daa-41c5-8ed6-e0e4660aba2b 61 fields · synced Jul 10, 2026
- EUDAMED 4cf24d01-a00b-4f0f-a858-942225f66938 61 fields · synced May 19, 2026