Skip to content

Sterile Rotary Files

by Shenzhen Superline Technology Co., Ltd. 789 variants

Ref AB2CP07H4BModel U, U+, U Blue, U Grey, O, O+, X, X+, X Blue, X Grey, V, V+, V Blue, W+, W Blue, A, A+, T, T+, GF, Sun, PRG, PTF, KV, KV+, KV Blue, W+ Tunnel, Theta, KD Blue, MH, DT+, DT Blue, KM, KM Blue, EZ-PASS, Z, FSa, FSb

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69448351ENDO03SR3N Basic UDI-DI 06944835131741UDI-DIDate20 Apr 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  • Withdrawn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

Model / Reference
U, U+, U Blue, U Grey, O, O+, X, X+, X Blue, X Grey, V, V+, V Blue, W+, W Blue, A, A+, T, T+, GF, Sun, PRG, PTF, KV, KV+, KV Blue, W+ Tunnel, Theta, KD Blue, MH, DT+, DT Blue, KM, KM Blue, EZ-PASS, Z, FSa, FSb, AB2CP07H4B
Primary DI / UDI-DI
06944835131741
Basic UDI-DI
69448351ENDO03SR3N
Direct Marketing DI
06944835131741
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000027059
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Superline Technology Co., Ltd.

See all devices from Shenzhen Superline Technology Co., Ltd. →

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