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Immunoglobulin G Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref IgG6011Y, IgG6012Y, IgG6013Y, IgG6014Y, IgG6015Y, IgG6011N, IgG6012N, IgG6013N, IgG6014N, IgG6015N
Identity
- Trade Name
- Immunoglobulin G Reagent Kit EUDAMED
- Device Name
- Immunoglobulin G Reagent Kit EUDAMED
- Model / Reference
- IgG6011Y, IgG6012Y, IgG6013Y, IgG6014Y, IgG6015Y, IgG6011N, IgG6012N, IgG6013N, IgG6014N, IgG6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IgG601K7 EUDAMED
- Basic UDI-DI
- B-IgG601K7 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G 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: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
This Immunoglobulin G Reagent Kit provides a reliable and accurate method for diagnosing and monitoring IgG antibody levels in patients, making it an essential tool in immunology research and clinical practice.
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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-IgG601K7 | 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 (2)
- EUDAMED e6771b31-b0dc-4ede-bf22-7dc92d4d28d3 61 fields · synced Jul 14, 2026
- EUDAMED e6771b31-b0dc-4ede-bf22-7dc92d4d28d3-1 61 fields · synced Jun 9, 2026