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Septofil N 02

by EASTDENT Co., Ltd

Part of a family of 12 devices: see the family page

Ref 11535KModel Smartcord

Septofil N 02 (11535K) is a medical device (EU MDR Class I; EMDN category retraction wires and gingival retractors) made by Eastdent Co., Ltd, registered in EUDAMED on 29 Apr 2026 (Basic UDI-DI 880937041001177), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880937041001177 Basic UDI-DI 08809370410424UDI-DIDate29 Apr 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Gingival Retraction Cord
Model / reference
Smartcord, 11535K
Primary DI / UDI-DI
08809370410424
Basic UDI-DI
880937041001177
EMDN code
Q010204 Retraction wires and gingival retractors
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000022583
Authorised representative
KTR Europe GmbH DE-AR-000005685

Similar devices in this category

Other devices filed under RETRACTION WIRES AND GINGIVAL RETRACTORS.

Other devices from Eastdent Co., Ltd

See all devices from Eastdent Co., Ltd →

Properties

Other properties (14, all answered No)