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MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR
EUDAMEDClass IVD General (EU MDR)
Ref KG198696
Identity
- Trade Name
- MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR EUDAMED
- Device Name
- MutaPLEX® GastroSys1 Mulitplex-Test: Adenovirus, Norovirus (GI & II), Rotavirus, PCR EUDAMED
- Model / Reference
- KG198696 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598002432 EUDAMED
- Basic UDI-DI
- B-04050598002432 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS 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
MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR 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-04050598002432 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED 06709142-94d5-4a27-8141-56e9559514d6 61 fields · synced Jul 12, 2026