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Silicone Dispenser Gun

EUDAMED

Class I (EU MDR)

Ref P10-1Model P1-1,P10-1,ZDQ01Ref P1-1

by Anson Investment Development Co., Ltd.

Identity

Trade Name
Silicone Dispenser Gun EUDAMED
Device Name
Dental Material Dispenser EUDAMED
Model / Reference
P1-1,P10-1,ZDQ01 EUDAMED
P10-1 EUDAMED
P1-1 EUDAMED

Identifiers

Primary DI / UDI-DI
06978049071104 EUDAMED
06978049071098 EUDAMED
Basic UDI-DI
697804907P10SC EUDAMED
EMDN Code
Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Category: Dental appliance fabrication material, ceramic

Silicone Dispenser Gun by Anson Investment Development Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000049926
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED 78f441ef-7fcc-4c29-bab1-d46680132491 61 fields · synced Jul 23, 2026
  • EUDAMED 55e878e9-6bd5-4512-9bb4-485430189e44 61 fields · synced May 19, 2026