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Apolipoprotein B
EUDAMEDClass IVD General (EU MDR)
Ref ABTUR-B00/ATERef ABTUR-H00/AURef ABTUR-H00/ALIRef ABTUR-L00/CGRRef ABTUR-H00/CGRRef ABTUR-L00/ALIRef ABTUR-L00/ADVRef ABTUR-H00/ARCRef ABTUR-B00/ARCRef ABTUR-B00Ref ABTUR-B00/CGRRef ABTUR-H00/ADVRef ABTUR-B00/AURef ABTUR-B00/ADVRef ABTUR-B00/UDARef ABTUR-L00/ARCRef ABTUR-H00/COBRef ABTUR-H00Ref ABTUR-H00/UDARef ABTUR-L00/COBRef ABTUR-L00/ATE
by Diagam S.A.
Identity
- Trade Name
- Apolipoprotein B EUDAMED
- Device Name
- Apolipoprotein B EUDAMED
- Model / Reference
- ABTUR-B00/ATE EUDAMEDABTUR-H00/AU EUDAMEDABTUR-H00/ALI EUDAMEDABTUR-L00/CGR EUDAMEDABTUR-H00/CGR EUDAMEDABTUR-L00/ALI EUDAMEDABTUR-L00/ADV EUDAMEDABTUR-H00/ARC EUDAMEDABTUR-B00/ARC EUDAMEDABTUR-B00 EUDAMEDABTUR-B00/CGR EUDAMEDABTUR-H00/ADV EUDAMEDABTUR-B00/AU EUDAMEDABTUR-B00/ADV EUDAMEDABTUR-B00/UDA EUDAMEDABTUR-L00/ARC EUDAMEDABTUR-H00/COB EUDAMEDABTUR-H00 EUDAMEDABTUR-H00/UDA EUDAMEDABTUR-L00/COB EUDAMEDABTUR-L00/ATE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168006682 EUDAMED05415168000727 EUDAMED05415168006101 EUDAMED05415168010399 EUDAMED05415168007061 EUDAMED05415168008662 EUDAMED05415168008174 EUDAMED05415168002035 EUDAMED05415168002028 EUDAMED05415168000055 EUDAMED05415168010382 EUDAMED05415168001335 EUDAMED05415168000710 EUDAMED05415168001328 EUDAMED05415168015684 EUDAMED05415168009393 EUDAMED05415168002646 EUDAMED05415168000062 EUDAMED05415168016056 EUDAMED05415168015202 EUDAMED05415168009584 EUDAMED
- Basic UDI-DI
- B-05415168006682 EUDAMEDB-05415168000727 EUDAMEDB-05415168006101 EUDAMEDB-05415168010399 EUDAMEDB-05415168007061 EUDAMEDB-05415168008662 EUDAMEDB-05415168008174 EUDAMEDB-05415168002035 EUDAMEDB-05415168002028 EUDAMEDB-05415168000055 EUDAMEDB-05415168010382 EUDAMEDB-05415168001335 EUDAMEDB-05415168000710 EUDAMEDB-05415168001328 EUDAMEDB-05415168015684 EUDAMEDB-05415168009393 EUDAMEDB-05415168002646 EUDAMEDB-05415168000062 EUDAMEDB-05415168016056 EUDAMEDB-05415168015202 EUDAMEDB-05415168009584 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
Category: Apolipoprotein B (Apo B) IVD, reagent
Apolipoprotein B by Diagam S.A. — Class IVD General — IVDD — 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
- 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
- 5’-Nucleotidase 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05415168006682 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (21)
- EUDAMED a58e8aa1-0ec3-4586-989f-04a4ea42aca2 61 fields · synced Aug 1, 2026
- EUDAMED f91a3155-34c0-42aa-9d29-cc2128d68230 61 fields · synced May 16, 2026
- EUDAMED 76d29840-4bc5-428d-a220-104b3a8c177a 61 fields · synced May 16, 2026
- EUDAMED 98f46f03-d7d0-491f-890b-dc3a77ec851f 61 fields · synced May 17, 2026
- EUDAMED 10fcfd82-ae09-4a36-87bd-879fa9fd2807 61 fields · synced May 17, 2026
- EUDAMED b4852be5-6353-4c2d-b24f-d3573ea6229f 61 fields · synced May 17, 2026
- EUDAMED 3b833431-dd9f-47a6-a649-ef0bfcafea85 61 fields · synced May 17, 2026
- EUDAMED ee27d8ba-22b3-4651-a171-9b1f8f1445a2 61 fields · synced May 17, 2026
- EUDAMED 779f54b0-8cd6-4b28-b000-c7421542f615 61 fields · synced May 17, 2026
- EUDAMED 55e340d9-8a8f-4d89-964d-2fd95368c703 61 fields · synced May 17, 2026
- EUDAMED d74ecc6e-4959-4ee1-9c1a-f64943bb78ee 61 fields · synced May 17, 2026
- EUDAMED 91518871-d0c3-48d8-a8a3-dec56f13b138 61 fields · synced May 18, 2026
- EUDAMED 32d794bd-b049-4fb2-a414-ff28766957b4 61 fields · synced May 18, 2026
- EUDAMED a4a3ebcc-203f-4863-bb31-adfd242b4a70 61 fields · synced May 18, 2026
- EUDAMED 3faf1b1d-a36e-4823-9b61-834b262b4c5e 61 fields · synced May 18, 2026
- EUDAMED 9bc46df5-be3b-4894-acac-b7e1cbe20268 61 fields · synced May 18, 2026
- EUDAMED 5ff3dc72-7894-4961-987a-088d8eeae8d1 61 fields · synced May 19, 2026
- EUDAMED eea951ad-6222-45a4-bb50-04c903603db4 61 fields · synced May 19, 2026
- EUDAMED 68b23b8f-6617-4a4c-9ee8-b19d30d007ae 61 fields · synced May 19, 2026
- EUDAMED 40dc1f1d-669d-484c-b914-0d447a127bb2 61 fields · synced May 19, 2026
- EUDAMED 232c1d18-6a31-4ff6-b816-81b7850cd85c 61 fields · synced May 19, 2026