M2-PK/MMP9/MPO/GST-Pi/RBP4/Calprotectin/FIT Multi-Target Test Kits (Colloidal Gold Immunochromatography Method)

by FAMID Biomedical Technology (Tianjin) Co., Ltd.

Ref 50T/Kit, 100T/Kit, 1T/Kit

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06972838800043 Basic UDI-DI	Date28 Jan 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name: M2-PK/MMP9/MPO/GST-Pi/RBP4/Calprotectin/FIT Multi-Target Test Kits (Colloidal Gold Immunochromatography Method)
Model / Reference: 50T/Kit, 100T/Kit, 1T/Kit

Primary DI / UDI-DI: 06972838800043, 06972838800050, 06972838800036
Basic UDI-DI: B-06972838800043, B-06972838800050, B-06972838800036
EMDN Code: W010106020302 Urine sediment test kit (automated)

Device Class: Class IVD General
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000051665
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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IVD General

Properties

Reagent
Near-Patient Testing NoEUDAMEDYesEUDAMED
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Companion Diagnostics: No
Surgical Instrument: No