← Back to catalogue
Immunoglobulin A (IgA) Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32026010
Identity
- Device Name
- Immunoglobulin A (IgA) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 32026010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334803874 EUDAMED
- Basic UDI-DI
- B-06950334803874 EUDAMED
- EMDN Code
- W0102010101 IMMUNOGLOBULIN A 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
Immunoglobulin A (IgA) 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-06950334803874 | 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
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 557c3585-6685-4af2-910d-493c6895f3e2 61 fields · synced Jun 18, 2026