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saliva ejector

EUDAMED

Class I (EU MDR)

Ref OW-16-1Model OW-16-1 OW-16-2 OW-17-1 OW-17-2 OW-17-3 OW-18-1 OW-18-2 OW-19-1

by Dongguan Ouwen Medical Device Technology Co., Ltd

Identity

Device Name
saliva ejector EUDAMED
Model / Reference
OW-16-1 OW-16-2 OW-17-1 OW-17-2 OW-17-3 OW-18-1 OW-18-2 OW-19-1 EUDAMED
OW-16-1 EUDAMED

Identifiers

Primary DI / UDI-DI
06975702481003 EUDAMED
Basic UDI-DI
697570248SE01ML EUDAMED
EMDN Code
Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

saliva ejector by Dongguan Ouwen Medical Device Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000013171
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 98fb7b12-bf56-4e29-ae9a-66a38842dc4e 61 fields · synced Jun 18, 2026