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i File x

by Shanwei Perfect Medical Instruments Co., Ltd. EUDAMED

Active European Union

Ref V497 201 954 2504 025Model ET Files、V BLUE、MTF、TG6、TH6、TF4 etc

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Dental Root-Canal Instruments
Model / Reference
ET Files、V BLUE、MTF、TG6、TH6、TF4 etc, V497 201 954 2504 025
Primary DI / UDI-DI
06942200902538
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033003
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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