Singclean®

by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED

Ref IVD49-02-1tModel Cassette

EMDN W0105041101

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberIVDR 823886	Date17 Aug 2026Issued	StatusActive expires 16 Aug 2031
European Union	CE/IVDR	NumberB-06936020116404 Basic UDI-DI	Date17 Dec 2025Registered	StatusActive
European Union	CE/IVDD	NumberB-06936020116404 Basic UDI-DI	Date17 Dec 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates

1 certificate · EUDAMED

IVDR 823886 Issued

Technical documentation EU IVDR

Notified body

Notified body 2797

Issued
17 Aug 2026

Expires
16 Aug 2031

Specification

EUDAMED · synced 22 Oct 2026

Device Name: COVID-19 Test kit (Colloidal Gold Method)
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method)
Model / Reference: IVD49-02-1t, Cassette

Primary DI / UDI-DI: 06936020116404, 06936020141529
Basic UDI-DI: B-06936020116404, 69360201188X
EMDN Code: W0105041101, W0105099099

Device Class: Class IVD General
Class C
Market of Registration: Germany
Austria

Manufacturer details

EUDAMED SRN: CN-MF-000014098
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Singclean Medical Products Co., Ltd.

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Singclean®

Class B
Singclean

Class C
Earlibird®

Class B
Pepino®

Class B
Singclean®

Class B

See all devices from Hangzhou Singclean Medical Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Microbial Substances
Reagent
Self Testing NoEUDAMEDYesEUDAMED
Professional Testing

Other properties (6)

Sterile: No
Human Tissues: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (2)

EUDAMED ce496a7c-f008-448c-bcd9-985438853aaf 61 fields · synced 22 Oct 2026
EUDAMED 06936020141529|69360201188X 61 fields · synced 8 Oct 2026