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Compule Dispenser Gun Bullets

EUDAMED

Class I (EU MDR)

Ref /Model SDG01,SDG02,CG01,CG02

by Huanghua Promisee Dental Co.Ltd.

Identity

Trade Name
Compule Dispenser Gun Bullets EUDAMED
Device Name
Dental material bullet dispenser EUDAMED
Model / Reference
SDG01,SDG02,CG01,CG02 EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06954454001929 EUDAMED
Basic UDI-DI
69544540DMBD001JL EUDAMED
EMDN Code
Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Croatia 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

Compule Dispenser Gun Bullets by Huanghua Promisee Dental 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-000014766
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED 1cf47e48-2d00-4379-86c0-b802a2304eb2 61 fields · synced Oct 6, 2026