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Saliva Collection Kit

EUDAMED

Class A (EU MDR)

Ref Saliva Kit Without VTM 001Model 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 001 EUDAMED

Identifiers

Primary DI / UDI-DI
06973905960585 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

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000003370
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 82424166-395e-401b-82ff-fa51fa507d3f 61 fields · synced Oct 6, 2026