Identity
- Trade Name
- Dako Omnis Mixing Device EUDAMED
- Device Name
- Dako Omnis Mixing Device EUDAMED
- Model / Reference
- GC11630 EUDAMEDGC116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700571112168 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A050001MH EUDAMED
- EMDN Code
- W0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Dako Omnis Mixing Device by Agilent Technologies Singapore (International) Pte Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 570057P3007P3010A050001MH | 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 667643f8-eece-4fed-827b-f710453fbc17 61 fields · synced Jun 20, 2026