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Denflex Spring Endo file

by Denflex Co., Ltd. 24 variants

Ref SFTG6HL25#20F-B, SFTG6HL25#50R-B, SFTG6HL25#25F-S, SFTG6HL25#30R-B, SFTG6HL25#15F-S, SFTG6HL25#15R-S, SFTG6HL25#10R-S, SFTG6HL23#20R-B, SFTG6HL23#15R-S, SFTG6HL25#30F-S, SFTG6HL25#15R-B, SFTG6HL23#25F-S, SFTG6HL25#20R-S, SFTG6HL25#50F-S, SFTG6HL25#30F-B, SFTG6HL23#20F-S, SFTG6HL25#50R-S, SFTG6HL23#20R-S, SFTG6HL23#30F-B, SFTG6HL23#25F-B, SFTG6HL25#40R-B, SFTG6HL25#25F-B, SFTG6HL23#15F-B, SFTG6HL23#15F-S, SFPATHHL23#00F, SFTG6HL23#10F-S, SFTG6HL25#10F-B

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-08800181602183 Basic UDI-DIDate29 Dec 2022RegisteredStatusActive

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  • Withdrawn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
SFTG6HL25#20F-B, SFTG6HL25#50R-B, SFTG6HL25#25F-S, SFTG6HL25#30R-B, SFTG6HL25#15F-S, SFTG6HL25#15R-S, SFTG6HL25#10R-S, SFTG6HL23#20R-B, SFTG6HL23#15R-S, SFTG6HL25#30F-S, SFTG6HL25#15R-B, SFTG6HL23#25F-S, SFTG6HL25#20R-S, SFTG6HL25#50F-S, SFTG6HL25#30F-B, SFTG6HL23#20F-S, SFTG6HL25#50R-S, SFTG6HL23#20R-S, SFTG6HL23#30F-B, SFTG6HL23#25F-B, SFTG6HL25#40R-B, SFTG6HL25#25F-B, SFTG6HL23#15F-B, SFTG6HL23#15F-S, SFPATHHL23#00F, SFTG6HL23#10F-S, SFTG6HL25#10F-B
Primary DI / UDI-DI
08800181602183, 08800181602541, 08800181602213, 08800181602503, 08800181602138, 08800181602374, 08800181602336, 08800181602404, 08800181602350, 08800181602251, 08800181602381, 08800181602190, 08800181602411, 08800181602299, 08800181602268, 08800181602152, 08800181602534, 08800181602398, 08800181602244, 08800181602206, 08800181602527, 08800181602220, 08800181602121, 08800181602114, 08800181602558, 08800181602077, 08800181602107
Basic UDI-DI
B-08800181602183, B-08800181602541, B-08800181602213, B-08800181602503, B-08800181602138, B-08800181602374, B-08800181602336, B-08800181602404, B-08800181602350, B-08800181602251, B-08800181602381, B-08800181602190, B-08800181602411, B-08800181602299, B-08800181602268, B-08800181602152, B-08800181602534, B-08800181602398, B-08800181602244, B-08800181602206, B-08800181602527, B-08800181602220, B-08800181602121, B-08800181602114, B-08800181602558, B-08800181602077, B-08800181602107
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
KR-MF-000030617
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Reusable

Other properties (10)

  • Sterile: No
  • Implantable: 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