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Immunoglobulin A Kit (immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3012546Model R1: 1x50mL, R2: 1x10mLRef 3000932Model Calibration sample: 1×1mLRef 3000930Ref 3021621Model R1: 1x50mL, R2: 1x10mL,Ref 3023541Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL, Ref 3021153Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL,
Identity
- Trade Name
- IMMUNOGLOBULIN A KIT (IMMUNOTURBIDIMETRIC METHOD) EUDAMED
- Device Name
- IMMUNOGLOBULIN A KIT (IMMUNOTURBIDIMETRIC METHOD) EUDAMED
- Model / Reference
- R1: 1x50mL, R2: 1x10mL EUDAMED3012546 EUDAMEDCalibration sample: 1×1mL EUDAMED3000932 EUDAMED3000930 EUDAMEDR1: 1x50mL, R2: 1x10mL, EUDAMED3021621 EUDAMEDR1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL, EUDAMED3023541 EUDAMED3021153 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260193 EUDAMED06942202261695 EUDAMED06942202246838 EUDAMED06925794592842 EUDAMED06942202215940 EUDAMED06942202260186 EUDAMED
- Basic UDI-DI
- B-06942202260193 EUDAMEDB-06942202261695 EUDAMEDB-06942202246838 EUDAMEDB-06925794592842 EUDAMEDB-06942202215940 EUDAMEDB-06942202260186 EUDAMED
- EMDN Code
- W0102010101 IMMUNOGLOBULIN A 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
Immunoglobulin A Kit (immunoturbidimetric Method) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942202260193 | 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 (6)
- EUDAMED 7ecdfef1-0791-41e7-ba00-e7b1259f6366 61 fields · synced Sep 18, 2026
- EUDAMED 90f5e38f-72ce-441c-8843-d7088ee75c26 61 fields · synced May 18, 2026
- EUDAMED 28be259e-e3c1-4c43-9aa6-6dbfb1833bab 61 fields · synced May 19, 2026
- EUDAMED 0941239f-749a-4282-89af-cffe6921c5ab 61 fields · synced Jul 9, 2026
- EUDAMED a3ac9163-c53d-4815-a76d-d0bb67607102 61 fields · synced Jul 26, 2026
- EUDAMED 867e73c7-42ba-4016-b90a-53e332655409 61 fields · synced Sep 18, 2026