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Apolipoprotein A1 Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref APOA16011Y, APOA16012Y, APOA16013Y, APOA16014Y, APOA16015Y, APOA16011N, APOA16012N, APOA16013N, APOA16014N, APOA16015NRef APOE6011Y, APOE6012Y, APOE6013Y, APOE6014Y, APOE6015Y, APOE6011N, APOE6012N, APOE6013N, APOE6014N, APOE6015N
Identity
- Trade Name
- Apolipoprotein A1 Reagent Kit EUDAMEDApolipoprotein E Reagent Kit EUDAMED
- Device Name
- Apolipoprotein A1 Reagent Kit EUDAMEDApolipoprotein E Reagent Kit EUDAMED
- Model / Reference
- APOA16011Y, APOA16012Y, APOA16013Y, APOA16014Y, APOA16015Y, APOA16011N, APOA16012N, APOA16013N, APOA16014N, APOA16015N EUDAMEDAPOE6011Y, APOE6012Y, APOE6013Y, APOE6014Y, APOE6015Y, APOE6011N, APOE6012N, APOE6013N, APOE6014N, APOE6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-APOA1601ED EUDAMEDD-APOE601WG EUDAMED
- Basic UDI-DI
- B-APOA1601ED EUDAMEDB-APOE601WG EUDAMED
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMEDW0102010404 APOLIPOPROTEIN E SUB-TYPING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.
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- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
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- 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-APOA1601ED | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (4)
- EUDAMED f373d688-b263-4c6f-ba04-a06e9b730299 61 fields · synced Jul 27, 2026
- EUDAMED f373d688-b263-4c6f-ba04-a06e9b730299-1 61 fields · synced Jun 9, 2026
- EUDAMED 88080c46-99d0-490c-92ed-2df579841ee6-1 61 fields · synced Jul 18, 2026
- EUDAMED 88080c46-99d0-490c-92ed-2df579841ee6-2 61 fields · synced Jul 18, 2026