dBest H. Pylori Saliva (HPS) Test Kit

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref R102-112

by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

Identity

Device Name: dBest H. Pylori Saliva (HPS) Test Kit EUDAMED
Model / Reference: R102-112 EUDAMED

Identifiers

Primary DI / UDI-DI: 06941571802324 EUDAMED
Basic UDI-DI: B-06941571802324 EUDAMED
EMDN Code: W0105090102 H. PYLORI - RT & POC EUDAMED

Classification

Device Class: Class IVD devices for self-testing EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

dBest H. Pylori Saliva (HPS) Test Kit by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. — Class IVD devices for self-testing — CE/MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	B-06941571802324	Class IVD devices for self-testing	Active

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Manufacturer

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
EUDAMED SRN: CN-MF-000020607
Authorised Representative: CEpartner4U NL-AR-000000111

Sources (1)

EUDAMED 459f591d-51e1-40a8-8be5-2902482d1811 61 fields · synced Oct 6, 2026