Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED

Ref GCKal-402a

EMDN W0105050205

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-GCKal-402aNM Basic UDI-DI	Date12 May 2026Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference: GCKal-402a

Primary DI / UDI-DI: D-GCKal-402aNM
Basic UDI-DI: B-GCKal-402aNM
EMDN Code: W0105050205 Leishmania

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000017965
Authorised representative: CMC Medical Devices & Drugs SL ES-AR-000000293

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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 f2f2c42b-0707-4ac9-858e-7e5866274a43 61 fields · synced 23 Oct 2026