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Endostep

by Shanwei Perfect Medical Instruments Co., Ltd. EUDAMED 179 variants

Active European Union

Ref Z497 201 932 2106 045Model ET Files、V BLUE、MTF、TG6、TH6、TF4 etc

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697590932NiTiRotary96 Basic UDI-DIDate23 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

Specification

EUDAMED

Device Name
Dental Root-Canal Instruments
Model / Reference
ET Files、V BLUE、MTF、TG6、TH6、TF4 etc, Z497 201 932 2106 045
Primary DI / UDI-DI
06942200977345
Basic UDI-DI
697590932NiTiRotary96
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
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