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dental resin filling instrument

by Foshan Minxin Medical Equipment Co., Ltd

Ref CT1Model CT1 CT2 CT3 CT4 CT5 CT6 CT7 CT8 CT9 CT10 CT11 CT12 CT13 CT14 CT15 CT16 CT17 CT18 CT19 MX3001 MX3002 MX3003 MX3004 MX3005 MX3006 MX3007 MX3008 MX3009 MX30010 MX30011 MX30012 etc

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697786858FSMX001GX Basic UDI-DI 06977868580002UDI-DIDate26 Sep 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
dental resin filling instrument
Model / Reference
CT1 CT2 CT3 CT4 CT5 CT6 CT7 CT8 CT9 CT10 CT11 CT12 CT13 CT14 CT15 CT16 CT17 CT18 CT19 MX3001 MX3002 MX3003 MX3004 MX3005 MX3006 MX3007 MX3008 MX3009 MX30010 MX30011 MX30012 etc, CT1
Primary DI / UDI-DI
06977868580002
Basic UDI-DI
697786858FSMX001GX
EMDN Code
Q0199 Odontology devices - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000043847
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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