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M3-L Blue

by United Dental Changzhou

Ref MLB0007021020Model PlaEU/LB/CCOB/M3RB/Mr/Fla/AF BLUE S ONE/AF BLUE R3/Blue Flex One/SBlue/Ni-ONE RECIPROC BLA/Pro/Easy One/Easy Rec

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697312285UDGRCF003N9 Basic UDI-DI 06942135214638UDI-DIDate11 May 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  • Withdrawn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

Device Name
Root Canal Files
Model / Reference
PlaEU/LB/CCOB/M3RB/Mr/Fla/AF BLUE S ONE/AF BLUE R3/Blue Flex One/SBlue/Ni-ONE RECIPROC BLA/Pro/Easy One/Easy Rec, MLB0007021020
Primary DI / UDI-DI
06942135214638
Basic UDI-DI
697312285UDGRCF003N9
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018453
Authorised representative
Caretechion GmbH DE-AR-000005946

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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