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Gutta Cutter

by ZOGEAR Medical Co., Ltd.

Ref GC-1000

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697484312GC-100074 Basic UDI-DI 06974843121496UDI-DIDate5 Nov 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
GC-1000
Primary DI / UDI-DI
06974843121496
Basic UDI-DI
697484312GC-100074
EMDN Code
Q0199 Odontology devices - other
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000012353
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from ZOGEAR Medical Co., Ltd.

See all devices from ZOGEAR Medical Co., Ltd. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No