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EnVision FLEX, High pH (Dako Omnis)
EUDAMEDClass A (EU MDR)
Ref GV800Model GV80011-2
Identity
- Trade Name
- EnVision FLEX, High pH (Dako Omnis) EUDAMED
- Device Name
- EnVision FLEX, High pH (Dako Omnis) EUDAMED
- Model / Reference
- GV80011-2 EUDAMEDGV800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572033455 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A023401MR 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
Yes
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, High pH (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 | 570057P3007P3010A023401MR | 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 89a7cac0-831b-4bb6-81f2-a4301e2a231d 61 fields · synced Jul 14, 2026