Identity
- Trade Name
- IDK® anti-SARS-CoV-2 IgM ELISA EUDAMED
- Device Name
- IDK® anti-SARS-CoV-2 IgM ELISA EUDAMED
- Model / Reference
- K 5001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598006294 EUDAMED
- Basic UDI-DI
- B-04050598006294 EUDAMED
- EMDN Code
- W0105041104 CORONAVIRUS IGM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
IDK® anti-SARS-CoV-2 IgM ELISA by Immundiagnostik AG — 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-04050598006294 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED 66ec4498-6992-43e5-9abc-4566f5e8f2c0 61 fields · synced Jul 13, 2026