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Immunoglobulin G (IgG) Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 120H160TRef 120H60TSCRef 120H160TSC
Identity
- Trade Name
- Immunoglobulin G (IgG) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Immunoglobulin G (IgG) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 120H160T EUDAMED120H60TSC EUDAMED120H160TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-120H160TEB EUDAMEDD-120H60TSCZU EUDAMEDD-120H160TSCHF EUDAMED
- Basic UDI-DI
- B-120H160TEB EUDAMEDB-120H60TSCZU EUDAMEDB-120H160TSCHF 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
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
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Immunoglobulin G (IgG) Assay Kit (Immunoturbidimetric Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-120H160TEB | 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 c4d0bce2-0fac-46bb-8cbe-91f2fecd0a66 61 fields · synced Oct 6, 2026
- EUDAMED f69c2da7-6307-4662-8dbb-d9a00a3b6803 61 fields · synced May 18, 2026
- EUDAMED f4612fec-bc74-487e-b85b-d82e0e2005a5 61 fields · synced May 18, 2026