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Immunoglobulin G Kit（immunoturbidimetric Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000945Model Calibration sample: 1×1mLRef 3000943Model R1: 1x50mL, R2: 1x10mLRef 3021620Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL, Ref 3023549Ref 3021667
Identity
- Trade Name
- IMMUNOGLOBULIN G KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Device Name
- IMMUNOGLOBULIN G KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Model / Reference
- Calibration sample: 1×1mL EUDAMED3000945 EUDAMEDR1: 1x50mL, R2: 1x10mL EUDAMED3000943 EUDAMEDR1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL, EUDAMED3021620 EUDAMED3023549 EUDAMED3021667 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261701 EUDAMED06942202246845 EUDAMED06925794592873 EUDAMED06942202215926 EUDAMED06925794592880 EUDAMED
- Basic UDI-DI
- B-06942202261701 EUDAMEDB-06942202246845 EUDAMEDB-06925794592873 EUDAMEDB-06942202215926 EUDAMEDB-06925794592880 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
Animal Tissues
No
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: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Immunoglobulin G Kit（immunoturbidimetric Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06942202261701 | 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 (5)
- EUDAMED 2ce961c1-35ba-4680-b890-5c8a6852ec08 61 fields · synced Jul 18, 2026
- EUDAMED 1a62581d-77c0-4a8a-9f07-d59c0b66ead2 61 fields · synced May 19, 2026
- EUDAMED 04ff274a-7d63-4da3-9cf1-04af59055774 61 fields · synced Jul 10, 2026
- EUDAMED 23f696a0-a1da-42f8-b233-9964a79e3418 61 fields · synced Jul 15, 2026
- EUDAMED c10cfbfe-75ad-4133-8956-460f8e11b094 61 fields · synced Jul 18, 2026