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EnVision FLEX DAB+ Substrate Chromogen System (Dako Omnis)
EUDAMEDClass A (EU MDR)
Ref GV825Model GV82511-2
Identity
- Trade Name
- EnVision FLEX DAB+ Substrate Chromogen System (Dako Omnis) EUDAMED
- Device Name
- EnVision FLEX DAB+ Substrate Chromogen System (Dako Omnis) EUDAMED
- Model / Reference
- GV82511-2 EUDAMEDGV825 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572033516 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A024001MC EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (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
No
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
EnVision FLEX DAB+ Substrate Chromogen System (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 | 570057P3007P3010A024001MC | 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 def3a719-4f64-414c-9a7b-202e4fa7f039 61 fields · synced Jul 11, 2026