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Envision FLEX DAB Enhancer (Dako Omnis)
EUDAMEDClass A (EU MDR)
Ref GC806Model GC80611-2
Identity
- Trade Name
- Envision FLEX DAB Enhancer (Dako Omnis) EUDAMED
- Device Name
- Envision FLEX DAB Ehhancer (Dako Omnis) EUDAMED
- Model / Reference
- GC80611-2 EUDAMEDGC806 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700573001309 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A029401P3 EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) 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 DAB Enhancer (Dako Omnis) by Agilent Technologies, Inc. — 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 | 570057P3007P3010A029401P3 | Class A | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
- EUDAMED SRN
- US-MF-000009385
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED 100818ef-f31c-4451-95ad-cfb1b2b9f408 61 fields · synced Jun 19, 2026