SENTiFIT 800

by Furuno Electric Co., Ltd. Japan EUDAMED

Ref 550800 EMDN W0201010102

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number0456016SENTiFIT9D Basic UDI-DI	Date13 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Withdrawn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 23 Oct 2026

Device Name: SENTiFIT ®800 Analyzer
Model / Reference: 550800

Primary DI / UDI-DI: 04560161906895
Basic UDI-DI: 0456016SENTiFIT9D
Direct Marketing DI: 04560161906895
EMDN Code: W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)

Device Class: Class A
Market of Registration: Ireland

Manufacturer details

EUDAMED SRN: JP-MF-000026828
Authorised representative: MedEnvoy Global BV NL-AR-000024028

Other devices from Furuno Electric Co., Ltd.

L Solution

Class A
Wash Solution NO.3

Class A
Detergent Solution

Class A
Internal Standard

Class A
Diluent

Class A
Ref Solution

Class A

See all devices from Furuno Electric Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Professional Testing
Surgical Instrument

Other properties (9)

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

Sources (1)

EUDAMED 6f6ed64c-a1d1-4a93-8831-33337a289e6d 61 fields · synced 23 Oct 2026