Saliva Collection Kit

EUDAMED

Class A (EU MDR)

Ref Saliva Kit without VTMModel Saliva Kit 001;Saliva Kit 002;Saliva Kit Without VTM 001;Saliva Kit Without VTM 002;Full Saliva Kit;Saliva Kit without VTM.

by Shandong Chengwu Medical Products Factory

Identity

Device Name: Saliva Collection Kit EUDAMED
Model / Reference: Saliva Kit 001;Saliva Kit 002;Saliva Kit Without VTM 001;Saliva Kit Without VTM 002;Full Saliva Kit;Saliva Kit without VTM. EUDAMED
Saliva Kit without VTM EUDAMED

Identifiers

Primary DI / UDI-DI: 06973905960516 EUDAMED
Basic UDI-DI: 697390596SCK01RC EUDAMED
EMDN Code: W05019002 SALIVA COLLECTION DEVICES EUDAMED

Classification

Device Class: Class A EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Saliva Collection Kit by Shandong Chengwu Medical Products Factory — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

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	697390596SCK01RC	Class A	Active

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Manufacturer

Manufacturer: Shandong Chengwu Medical Products Factory
EUDAMED SRN: CN-MF-000003370
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (1)

EUDAMED 29753ad7-8730-408c-9554-ebf736fcf4a0 61 fields · synced Jun 19, 2026