← Back to catalogue
Immunoglobulin G4 (IgG4) Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32027190
Identity
- Trade Name
- Immunoglobulin G4 (IgG4) Detection Kit (Nephelometry) EUDAMED
- Device Name
- Immunoglobulin G4 (IgG4) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 32027190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334819684 EUDAMED
- Basic UDI-DI
- B-06950334819684 EUDAMED
- EMDN Code
- W0102010106 IMMUNOGLOBULIN G SUBCLASS REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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 G4 (IgG4) Detection Kit (Nephelometry) by Genrui Biotech Inc. — 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-06950334819684 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED bcf47253-7438-423b-aae9-e6ee56dfdb1b 61 fields · synced Jun 18, 2026