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Air motor set

EUDAMED

Class IIa (EU MDR)

Ref GS-KIT X2M4 / 805000180Model GS SeriesRef GS-KIT X1B2 / 805000380Ref GS-KIT X1M4 / 805000480Ref GS-KIT X2B2 / 805000280

by Foshan Koungsun Medical Technology Co., Ltd.

Identity

Trade Name
Air motor set EUDAMED
Device Name
Dental handpiece EUDAMED
Model / Reference
GS Series EUDAMED
GS-KIT X2M4 / 805000180 EUDAMED
GS-KIT X1B2 / 805000380 EUDAMED
GS-KIT X1M4 / 805000480 EUDAMED
GS-KIT X2B2 / 805000280 EUDAMED

Identifiers

Primary DI / UDI-DI
06977190340473 EUDAMED
06977190340466 EUDAMED
06977190340459 EUDAMED
06977190340480 EUDAMED
Basic UDI-DI
697719034GSTiTK EUDAMED
EMDN Code
L15900801 PNEUMATIC SYSTEM TIPS FOR DENTAL USE, REUSABLE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Ireland 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

Air motor set by Foshan Koungsun Medical Technology Co., Ltd. — Class IIa — 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

Manufacturer
Foshan Koungsun Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000045023
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (4)

  • EUDAMED 4aa4397d-03eb-4cde-801c-f1eb1948ac0c 61 fields · synced Jul 30, 2026
  • EUDAMED 46bd7329-a1f2-4808-8b83-5773fbc494b1 61 fields · synced May 17, 2026
  • EUDAMED d13ec5cb-ffc7-46f5-bab2-493ff37ca95e 61 fields · synced May 18, 2026
  • EUDAMED 2a69a13c-6f81-4459-8ddd-e4a3630b9e5a 61 fields · synced May 19, 2026