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Apolipoprotein A1 Reagent Kit（immunoturbidimetric Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3012524Model R1: 1x50mL, R2: 1x10mLRef 3001037Model Calibration sample: 1×1mL
Identity
- Trade Name
- APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Device Name
- APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Model / Reference
- R1: 1x50mL, R2: 1x10mL EUDAMED3012524 EUDAMEDCalibration sample: 1×1mL EUDAMED3001037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261152 EUDAMED06942202261763 EUDAMED
- Basic UDI-DI
- B-06942202261152 EUDAMEDB-06942202261763 EUDAMED
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMEDW0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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（immunoturbidimetric Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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Also classified as Apolipoprotein A-I (Apo A1) IVD, reagent.
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- Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL 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-06942202261152 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 8633a860-3dc6-401f-a62e-2fa0e3e251c6 61 fields · synced Jul 28, 2026
- EUDAMED f97a304f-7d50-4287-8a85-2ba1de03ec39 61 fields · synced May 18, 2026