Identity
- Trade Name
- FLEX IHC Microscope Slides EUDAMED
- Device Name
- FLEX IHC Microscope Slides EUDAMED
- Model / Reference
- K802021-2 EUDAMEDK8020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700571110652 EUDAMED
- Basic UDI-DI
- 570057P3010P3007A023001GX EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES 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
Category: General specimen microscopy slide IVD, single-use
FLEX IHC Microscope Slides by Agilent Technologies Singapore (International) Pte Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 570057P3010P3007A023001GX | 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 8266036f-0680-4c7e-aae4-492650265133 61 fields · synced Jul 10, 2026