ChainFor Respiratory ID-4 Genotyping qPCR Kit

EUDAMED

Class IVD General (EU MDR)

Ref CFP13

by Vitrosens Biotechnology Inc.

Identity

Trade Name: ChainFor Respiratory ID-4 Genotyping qPCR Kit EUDAMED
Device Name: Respiratory ID-4 Genotyping qPCR Kit EUDAMED
Model / Reference: CFP13 EUDAMED

Identifiers

Primary DI / UDI-DI: 08683548256959 EUDAMED
Basic UDI-DI: B-08683548256959 EUDAMED
EMDN Code: W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS 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

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

Yes

EUDAMED

Surgical Instrument

Yes

EUDAMED

ChainFor Respiratory ID-4 Genotyping qPCR Kit by Vitrosens Biotechnology Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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-08683548256959	Class IVD General	Active

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Manufacturer

Manufacturer: Vitrosens Biotechnology Inc.
EUDAMED SRN: TR-MF-000026452

Sources (1)

EUDAMED c273ef6a-eda3-4f10-9d43-30df34956c41 61 fields · synced Jun 18, 2026