Human Papillomavirus Self Sample Collection Kit

by Jiangsu Mole Bioscience Co., LTD. China EUDAMED

Ref PH03010K06C2001 EMDN A1102

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697089547HPVSSC00X5 Basic UDI-DI	Date26 Oct 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Human Papillomavirus Self Sample Collection Kit
Model / Reference: PH03010K06C2001

Primary DI / UDI-DI: 06970895478601
Basic UDI-DI: 697089547HPVSSC00X5
EMDN Code: A1102 Sample collection swabs with transport medium

Device Class: Class A
Market of Registration: Hungary

Manufacturer details

EUDAMED SRN: CN-MF-000001539
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Self Testing

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Near-Patient Testing: No
Professional Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (1)

EUDAMED fe52cc06-62f0-4021-9736-4672b7e3bac9 61 fields · synced 22 Oct 2026