Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3013756Model 2×50Tests/KitRef 3013807Model 50Tests/Kit

by Dirui Industrial Co., Ltd

Identity

Trade Name: Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
"Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)" EUDAMED
Device Name: Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference: 2×50Tests/Kit EUDAMED
3013756 EUDAMED
50Tests/Kit EUDAMED
3013807 EUDAMED

Identifiers

Primary DI / UDI-DI: 06942202224140 EUDAMED
06925794520319 EUDAMED
Basic UDI-DI: B-06942202224140 EUDAMED
B-06925794520319 EUDAMED
EMDN Code: W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMEDEUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06942202224140	Class IVD General	Active

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Manufacturer

Manufacturer: Dirui Industrial Co., Ltd
EUDAMED SRN: CN-MF-000001891
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (2)

EUDAMED 72f1f5be-2e85-461d-9769-14b2e3bba65f 61 fields · synced Jul 8, 2026
EUDAMED 163eb2f5-e3a0-47d6-a2e0-ac80ce0a0003 61 fields · synced May 17, 2026