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Immunoglobulin G (IgG) Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32026014Model 25 testsRef 32080014Model 2*25 tests
Identity
- Device Name
- Immunoglobulin G (IgG) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 25 tests EUDAMED32026014 EUDAMED2*25 tests EUDAMED32080014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334803928 EUDAMED06950334802280 EUDAMED
- Basic UDI-DI
- B-06950334803928 EUDAMEDB-06950334802280 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Cyprus 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) Detection Kit (Nephelometry) by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06950334803928 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED a54a1784-ce2a-494d-9e89-91c7f047796c 61 fields · synced Jul 24, 2026
- EUDAMED b82b37e1-8730-43d8-a120-4af44ee21dfd 61 fields · synced May 17, 2026