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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Endodontic Files

UDI-DI 06941877800963Basic UDI-DI 697259778EF001KX

Class IIa · MDR · Changzhou Sifary Medical Technology Co., Ltd.

Identification
Model
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
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

6126956CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-03-31 · Expiry 2027-08-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Changzhou Sifary Medical Technology Co., Ltd.

SRN CN-MF-000010405

CN · Changzhou

manufacturer

Authorised representative: Caretechion GmbH (DE-AR-000005946)

Related UDI-DIs

Showing 12 of 2201 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/endodontic-files-0963 · UDI page: /udi/06941877800963

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