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Apolipoprotein A1
EUDAMEDClass IVD General (EU MDR)
Ref AATUR-B00/UDARef AATUR-H00/AURef AATUR-L00/ATERef AATUR-H00/ARCRef AATUR-B00Ref AATUR-L00/ADVRef AATUR-L00/ARCRef AATUR-H00/ATERef AATUR-L00/COBRef AATUR-B00/ATERef AATUR-B00/COBRef AATUR-B00/AURef AATUR-H00/ALIRef AATUR-L00/UDARef AATUR-B00/CGRRef AATUR-L00/CGRRef AATUR-H00/ADVRef AATUR-B00/ADV
by Diagam S.A.
Identity
- Trade Name
- Apolipoprotein A1 EUDAMED
- Device Name
- Apolipoprotein A1 EUDAMED
- Model / Reference
- AATUR-B00/UDA EUDAMEDAATUR-H00/AU EUDAMEDAATUR-L00/ATE EUDAMEDAATUR-H00/ARC EUDAMEDAATUR-B00 EUDAMEDAATUR-L00/ADV EUDAMEDAATUR-L00/ARC EUDAMEDAATUR-H00/ATE EUDAMEDAATUR-L00/COB EUDAMEDAATUR-B00/ATE EUDAMEDAATUR-B00/COB EUDAMEDAATUR-B00/AU EUDAMEDAATUR-H00/ALI EUDAMEDAATUR-L00/UDA EUDAMEDAATUR-B00/CGR EUDAMEDAATUR-L00/CGR EUDAMEDAATUR-H00/ADV EUDAMEDAATUR-B00/ADV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168015776 EUDAMED05415168000703 EUDAMED05415168009577 EUDAMED05415168002011 EUDAMED05415168000031 EUDAMED05415168008167 EUDAMED05415168009454 EUDAMED05415168007054 EUDAMED05415168015196 EUDAMED05415168006675 EUDAMED05415168002615 EUDAMED05415168000697 EUDAMED05415168006088 EUDAMED05415168015974 EUDAMED05415168010368 EUDAMED05415168010375 EUDAMED05415168001311 EUDAMED05415168001304 EUDAMED
- Basic UDI-DI
- B-05415168015776 EUDAMEDB-05415168000703 EUDAMEDB-05415168009577 EUDAMEDB-05415168002011 EUDAMEDB-05415168000031 EUDAMEDB-05415168008167 EUDAMEDB-05415168009454 EUDAMEDB-05415168007054 EUDAMEDB-05415168015196 EUDAMEDB-05415168006675 EUDAMEDB-05415168002615 EUDAMEDB-05415168000697 EUDAMEDB-05415168006088 EUDAMEDB-05415168015974 EUDAMEDB-05415168010368 EUDAMEDB-05415168010375 EUDAMEDB-05415168001311 EUDAMEDB-05415168001304 EUDAMED
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I 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 A-I (Apo A1) IVD, reagent
Apolipoprotein A1 by Diagam S.A. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.
- APOLIPOPROTEÍNA A1 — QUIMICA CLINICA APLICADA S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Nephstar Apo A1 Kit — Goldsite Diagnostics Inc. · IVD General
- APO A1 — Medicon Hellas SA · IVD General
- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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-05415168015776 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (18)
- EUDAMED b0915e57-778e-4849-8968-953ca67121e4 61 fields · synced Aug 4, 2026
- EUDAMED 46b098c7-3420-4e25-9d0d-77d20e6e9e3f 61 fields · synced May 16, 2026
- EUDAMED 2490c86a-d3be-49cc-a4bc-f06174c7b1f2 61 fields · synced May 16, 2026
- EUDAMED 22caf297-3a03-447d-bc62-5d050beba912 61 fields · synced May 16, 2026
- EUDAMED 41107c91-5fb2-4a9c-b24a-cbae8b5e712f 61 fields · synced May 17, 2026
- EUDAMED e97b4097-f810-472c-ac13-317b91684996 61 fields · synced May 17, 2026
- EUDAMED 7186ae76-09f5-4f66-ac5a-650c6c046d0f 61 fields · synced May 17, 2026
- EUDAMED 02d4ebb5-f680-4aea-838c-efe079b86fc1 61 fields · synced May 17, 2026
- EUDAMED 6bfdb181-a71d-4cf5-bf79-579e1df8c4bb 61 fields · synced May 18, 2026
- EUDAMED 9daac547-7adb-4228-ad10-b49762c78f85 61 fields · synced May 18, 2026
- EUDAMED 4c5f89d9-9484-4b23-9f53-ac7398728977 61 fields · synced May 18, 2026
- EUDAMED 81a9bde3-19c8-4080-a2bb-790af09ab810 61 fields · synced May 18, 2026
- EUDAMED 7e2aff5f-e707-4cc5-88db-b7584f138477 61 fields · synced May 18, 2026
- EUDAMED dafca8b3-10b2-4ac6-9789-e0a1caaf3778 61 fields · synced May 18, 2026
- EUDAMED 339b71eb-53c6-4cfc-badb-07a5108e09b1 61 fields · synced May 18, 2026
- EUDAMED f7163236-b8ac-4165-a131-d1f111f6ec29 61 fields · synced May 18, 2026
- EUDAMED 8cda55c1-44f5-4515-966d-b77e04d323fc 61 fields · synced May 18, 2026
- EUDAMED 3cc494bf-517b-4809-946f-701340e2d5e5 61 fields · synced May 19, 2026