EnVision FLEX Hematoxylin (Link)

by Agilent Technologies Singapore (International) Pte Ltd Singapore EUDAMED

Ref K8008Model K800821-2 EMDN W01029003

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number570057P3007P3010A024901NR Basic UDI-DI	Date26 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference: K800821-2, K8008

Primary DI / UDI-DI: 05700572030607
Basic UDI-DI: 570057P3007P3010A024901NR
EMDN Code: W01029003 Buffers (unassignable), supplem. reagents, etc (ic)

Device Class: Class A
Market of Registration: Denmark

Manufacturer details

EUDAMED SRN: SG-MF-000014448
Authorised representative: Agilent Technologies Denmark ApS DK-AR-000001443

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (1)

EUDAMED 05700572030607|570057P3007P3010A024901NR 61 fields · synced 25 Oct 2026