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MT Blue

by Shanwei Perfect Medical Instruments Co., Ltd. 120 variants

Ref Z498 201 945 2504 040Model File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc, ET Files、V BLUE、MTF、TG6、TH6、TF4 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Overview

Dental Root-Canal Instruments, such as the MT Blue, are precision instruments used in endodontic procedures. Designed for safe and effective root canal treatment, these instruments provide optimal cleaning and shaping of the dental pulp.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697590932SSTHandfilesJ4 Basic UDI-DI 06942200917563UDI-DIDate18 Jul 2025RegisteredStatusActive

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  • Withdrawn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
File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc, Z498 201 945 2504 040, ET Files、V BLUE、MTF、TG6、TH6、TF4 etc
Primary DI / UDI-DI
06942200917563
Basic UDI-DI
697590932SSTHandfilesJ4, 697590932NiTiRotary96
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-000033003
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanwei Perfect Medical Instruments Co., Ltd.

See all devices from Shanwei Perfect Medical Instruments Co., Ltd. →

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