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Immunoglobulin A Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref IgA6011Y, IgA6012Y, IgA6013Y, IgA6014Y, IgA6015Y, IgA6011N, IgA6012N, IgA6013N, IgA6014N, IgA6015N
Identity
- Trade Name
- Immunoglobulin A Reagent Kit EUDAMED
- Device Name
- Immunoglobulin A Reagent Kit EUDAMED
- Model / Reference
- IgA6011Y, IgA6012Y, IgA6013Y, IgA6014Y, IgA6015Y, IgA6011N, IgA6012N, IgA6013N, IgA6014N, IgA6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IgA601HV EUDAMED
- Basic UDI-DI
- B-IgA601HV EUDAMED
- EMDN Code
- W0102010101 IMMUNOGLOBULIN A 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
Immunoglobulin A Reagent Kit by Hangzhou Aichek Medical Technology 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-IgA601HV | 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 6f88dbaa-7e10-4a87-ac0a-722cfa0e7b0a 61 fields · synced Aug 1, 2026
- EUDAMED 6f88dbaa-7e10-4a87-ac0a-722cfa0e7b0a-1 61 fields · synced Jun 10, 2026