Human Glioma 26 Gene Mutations Detection Kit

by Xiamen Spacegen Co., Ltd. China EUDAMED

Ref SPG-GL001Model 16 Tests/kit

EMDN W0106030102

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberB-06972665700226 Basic UDI-DI	Date4 Mar 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: 16 Tests/kit, SPG-GL001

Primary DI / UDI-DI: 06972665700226
Basic UDI-DI: B-06972665700226
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 & raw data

Show properties, registry sources and raw records

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

Sources (1)

EUDAMED 090a0080-98f8-4d04-8854-ed486d1bc682 61 fields · synced 22 Oct 2026