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Immunoglobulin A (IgA) Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 121H60TRef 121H60TSCRef 121H160T
Identity
- Trade Name
- Immunoglobulin A (IgA) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Immunoglobulin A (IgA) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 121H60T EUDAMED121H60TSC EUDAMED121H160T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-121H60T3J EUDAMEDD-121H60TSC2G EUDAMEDD-121H160TEQ EUDAMED
- Basic UDI-DI
- B-121H60T3J EUDAMEDB-121H60TSC2G EUDAMEDB-121H160TEQ 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
No
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 (IgA) Assay Kit (Immunoturbidimetric Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-121H60T3J | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED 922d21ad-1424-4af8-b79f-c3c77e5da594 61 fields · synced Oct 6, 2026
- EUDAMED bd8c4e75-e865-4cfc-8d2d-e1f4fe1231d7 61 fields · synced May 17, 2026
- EUDAMED c329cbcf-53a5-46be-bfd9-e47212ab53a6 61 fields · synced May 19, 2026