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Fluorescence Mounting Medium (Dako Omnis)
EUDAMEDClass A (EU MDR)
Ref GM304Model GM30411-2
Identity
- Trade Name
- Fluorescence Mounting Medium (Dako Omnis) EUDAMED
- Device Name
- Fluorescence Mounting Medium (Dako Omnis) EUDAMED
- Model / Reference
- GM30411-2 EUDAMEDGM304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572033592 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A022501MP EUDAMED
- EMDN Code
- W01030706 MOUNTING MEDIA (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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
New Device
No
EUDAMED
Fluorescence Mounting Medium (Dako Omnis) by Agilent Technologies Singapore (International) Pte Ltd — Class A — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 570057P3007P3010A022501MP | Class A | Active |
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Manufacturer
- EUDAMED SRN
- SG-MF-000014448
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED dacf04f5-0cdd-4707-8c22-d8ee297cf7e9 61 fields · synced Jul 12, 2026