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Endodontic Files

by Changzhou Sifary Medical Technology Co., Ltd. EUDAMEDGUDID

Expiring European Union

Ref 5180406Model E-FLEX BLUE-XXX, E-FLEX EDGE-XXX, E-FLEX GOLD-XXX, E-FLEX MINI-XXX, E-FLEX ONE-XXX, E-FLEX REC-XXX, E-FLEX S-XXX, E-FLEX-XXX, E-STYLE BLUE, E-STYLE BLUE-XXX, E-STYLE GOLD, E-STYLE GOLD-XXX, E-Aurora-XXX, E-FLEX RT-XXX

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06941877825355 UDI-DIDate17 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6126956CE01 Date31 Mar 2025IssuedStatusExpiring expires 1 Aug 2027

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 6126956CE01 Expiring Supplemented Expires in 277 days

    Quality management system EU MDR

    Notified body
    0344
    Issued
    31 Mar 2025
    Expires
    1 Aug 2027
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Endodontic Files EUDAMED
Eighteeth GUDID
Generic Name
Rotary/reciprocating endodontic file/rasp, reusable
Model / Ref / Catalog
E-FLEX BLUE-XXX, E-FLEX EDGE-XXX, E-FLEX GOLD-XXX, E-FLEX MINI-XXX, E-FLEX ONE-XXX, E-FLEX REC-XXX, E-FLEX S-XXX, E-FLEX-XXX, E-STYLE BLUE, E-STYLE BLUE-XXX, E-STYLE GOLD, E-STYLE GOLD-XXX, E-Aurora-XXX, E-FLEX RT-XXX, 5180406, E-Aurora-056
Primary DI / UDI-DI
06941877825355
Basic UDI-DI
697259778EF001KX
FDA Product Code
EKS
EMDN Code
L159004 Endodontic rasps and files, reusable
GMDN Term
Rotary/reciprocating endodontic file/rasp, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
Market of Registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000010405
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Changzhou Sifary Medical Technology Co., Ltd.

See all devices from Changzhou Sifary Medical Technology Co., Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No