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Apo B
EUDAMEDClass IVD General (EU MDR)
Ref 1415-0560Ref 1418-0567Ref 1419-0560Ref 1417-0567
Identity
- Trade Name
- APO B EUDAMED
- Device Name
- APO B EUDAMED
- Model / Reference
- 1415-0560 EUDAMED1418-0567 EUDAMED1419-0560 EUDAMED1417-0567 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309168231 EUDAMED05204309071005 EUDAMED05204309123063 EUDAMED05204309137145 EUDAMED
- Basic UDI-DI
- B-05204309168231 EUDAMEDB-05204309071005 EUDAMEDB-05204309123063 EUDAMEDB-05204309137145 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Apo B by Medicon Hellas SA — 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
- 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05204309168231 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (4)
- EUDAMED 819e08d4-7ef4-4199-8873-11d9304a903e 61 fields · synced Jul 30, 2026
- EUDAMED 136919a6-9cf0-4abc-91c4-d9caf889c803 61 fields · synced May 17, 2026
- EUDAMED 366459a0-7b41-4a11-96fd-1832491681fa 61 fields · synced May 18, 2026
- EUDAMED b0330216-3cdb-4e37-8e3a-eedef5dd98a9 61 fields · synced May 18, 2026