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ISH Ethanol Solution 96% (Dako Omnis)
EUDAMEDClass A (EU MDR)
Ref GM300Model GM30011-2
Identity
- Trade Name
- ISH Ethanol Solution 96% (Dako Omnis) EUDAMED
- Device Name
- ISH Ethanol Solution 96% (Dako Omnis) EUDAMED
- Model / Reference
- GM30011-2 EUDAMEDGM300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572033554 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A022101M3 EUDAMED
- EMDN Code
- W01030703 DNA IN SITU HYBRIDISATION REAGENTS 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
ISH Ethanol Solution 96% (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 | 570057P3007P3010A022101M3 | 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 ec108809-c84a-4f2a-a857-e73c68d7b956 61 fields · synced Jun 19, 2026