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Sterile M3-Safe Path

by United Dental Changzhou 3 variants

Ref SMSPA002025010Model M3-Imms/M3-LPs/M3-MAX1s/M3-MAX3s/M3-Os/M3-Paths/M3-RTs/M3-SOs/M3-SPathLs/M3-SPaths/M3-TPs/M3-Ts/M3-WOs/UDG-CCEUs/UDG-CCPs/Shadows

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697312285UDGSRCF002L2 Basic UDI-DI 06942135223753UDI-DIDate18 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  • Withdrawn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
Sterile Root Canal Files
Model / Reference
M3-Imms/M3-LPs/M3-MAX1s/M3-MAX3s/M3-Os/M3-Paths/M3-RTs/M3-SOs/M3-SPathLs/M3-SPaths/M3-TPs/M3-Ts/M3-WOs/UDG-CCEUs/UDG-CCPs/Shadows, SMSPA002025010
Primary DI / UDI-DI
06942135223753
Basic UDI-DI
697312285UDGSRCF002L2
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
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

  • Sterile

Other properties (12)

  • 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