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Rotary Endo File

by Chengdu Sani Medical Equipment Co., Ltd. 147 variants

Ref /Model 04/50

Active European Union

CE MDD

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970602034526 Basic UDI-DI 06970602034526UDI-DIDate10 Jul 2024RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
04/50, /
Primary DI / UDI-DI
06970602034526
Basic UDI-DI
B-06970602034526
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class IIa
EU market of registration
Estonia

Manufacturer details

EUDAMED SRN
CN-MF-000011715
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Manual endodontic file/rasp, reusable

Other devices from Chengdu Sani Medical Equipment Co., Ltd

See all devices from Chengdu Sani Medical Equipment Co., Ltd →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No