ISE standard solution

by Dirui Industrial Co., Ltd China EUDAMED

Ref 3001221Model Low：3×10mL

EMDN W01010399

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberB-06942202261541 Basic UDI-DI	Date15 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: Low：3×10mL, 3001221

Primary DI / UDI-DI: 06942202261541
Basic UDI-DI: B-06942202261541
EMDN Code: W01010399 Electrolytes - other

Device Class: Class IVD General
Market of Registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000001891
Authorised representative: Emergo Europe B.V. NL-AR-000000116

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED 70f8f6d1-7dd1-4652-867a-bc93e940fc38 61 fields · synced 22 Oct 2026