Identity
- Trade Name
- IgG4 Screen OMNI1 EUDAMED
- Device Name
- IgG4 Screen OMNI1 EUDAMED
- Model / Reference
- ILE-SCG902 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260153751228 EUDAMED
- Basic UDI-DI
- B-04260153751228 EUDAMED
- EMDN Code
- W01020208 ALLERGENE SPECIFIC IGG EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
IgG4 Screen OMNI1 by Gold Standard Diagnostics Kassel GmbH — 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-04260153751228 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
- EUDAMED SRN
- DE-MF-000021646
Sources (1)
- EUDAMED e6033d1c-177f-42f6-940b-56ddfaffd6da 61 fields · synced Jun 19, 2026