Human Glioma 26 Gene Mutations Detection Kit

by Xiamen Spacegen Co., Ltd. EUDAMED

Active European Union

Ref SPG-GL002Model 32 Tests/kit

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06972665700356 Basic UDI-DI	Date4 Mar 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference: 32 Tests/kit, SPG-GL002

Primary DI / UDI-DI: 06972665700356
Basic UDI-DI: B-06972665700356
EMDN Code: W0106030102 Cyp 450 - multiple tests on micro-arrays

Device Class: Class IVD General
Market of Registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000018018
Authorised representative: JOYSUN GROUP S.L.U ES-AR-000043666

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Properties

Show properties

Human Tissues
Animal Tissues
Microbial Substances
Reagent
Professional Testing

Other properties (5)

Sterile: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No