Breast-Ovarian Cancer Combined Gene Detection Kit

by Xiamen Spacegen Co., Ltd. China EUDAMED

Ref SPG-BOC001Model 16 Tests/kit

EMDN W01060299

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06972665700004 Basic UDI-DI	Date4 Mar 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 22 Oct 2026

Model / Reference: 16 Tests/kit, SPG-BOC001

Primary DI / UDI-DI: 06972665700004
Basic UDI-DI: B-06972665700004
EMDN Code: W01060299 Tests for acquired genetic or chromosomal alterations - other

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 95adc7ea-7e1f-4ba6-bf44-539e5374fc99 61 fields · synced 22 Oct 2026