Breast-Ovarian Cancer Combined Gene Detection Kit

by Xiamen Spacegen Co., Ltd. China EUDAMED

Ref SPG-BOC002Model 32 Tests/kit

EMDN W01060299

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06972665700219 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 23 Oct 2026

Model / Reference: 32 Tests/kit, SPG-BOC002

Primary DI / UDI-DI: 06972665700219
Basic UDI-DI: B-06972665700219
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 5ddf43f3-682c-4da1-8d2a-818330b72980 61 fields · synced 23 Oct 2026