ISE Internal Standard Solution

by Dirui Industrial Co., Ltd China EUDAMED

Ref 3025467Model 2L/barrel

EMDN W01010399

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69422022W0101039903R0RU Basic UDI-DI	Date2 Sep 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: 2L/barrel, 3025467

Primary DI / UDI-DI: 06942202232855
Basic UDI-DI: 69422022W0101039903R0RU
EMDN Code: W01010399 Electrolytes - other

Device Class: Class A
Market of Registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000001891
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Dirui Industrial Co., Ltd

Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay)

Class C
C-Reactive Protein Reagent Kit (Latex Immunoturbidimetric Assay)

Class B
Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)

Class C
Anti-Streptolysin O Kit（latex Enhanced Immunoturbidimetric Assay）

IVD General
Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)

Class C
Focus

Class A

See all devices from Dirui Industrial Co., Ltd →

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 0ebb662e-2d5c-4e34-9b6e-fda41d4937c3 61 fields · synced 24 Oct 2026