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EnVision FLEX Target Retrieval Solution Low pH (50x) (Dako Omnis)
EUDAMEDClass A (EU MDR)
Ref GV805Model GV80511-2
Identity
- Trade Name
- EnVision FLEX Target Retrieval Solution Low pH (50x) (Dako Omnis) EUDAMED
- Device Name
- EnVision FLEX Target Retrieval Solution Low pH (50x) (Dako Omnis) EUDAMED
- Model / Reference
- GV80511-2 EUDAMEDGV805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572033479 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A023601N3 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
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
EnVision FLEX Target Retrieval Solution Low pH (50x) (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 | 570057P3007P3010A023601N3 | 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 a3b4e637-3f05-405a-9993-8992644cddb9 61 fields · synced Jul 20, 2026