Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay)

EUDAMED

Class IVD General (EU MDR)

Ref CP5-01

by Genobio Pharmaceutical Co., Ltd.

Identity

Device Name: Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay) EUDAMED
Model / Reference: CP5-01 EUDAMED

Identifiers

Primary DI / UDI-DI: 06970514081229 EUDAMED
Basic UDI-DI: B-06970514081229 EUDAMED
EMDN Code: W0105011799 BACTERIOLOGY IMMUNOASSAY - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay) by Genobio Pharmaceutical 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-06970514081229	Class IVD General	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Genobio Pharmaceutical Co., Ltd.
EUDAMED SRN: CN-MF-000027997
Authorised Representative: Caretechion GmbH DE-AR-000005946

Sources (1)

EUDAMED 03533613-95f6-4bd4-bf7d-cba0411d1f02 61 fields · synced Jul 15, 2026