Rotary Endo File

by Chengdu Sani Medical Equipment Co., Ltd. 147 variants

Ref /Model F2

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

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06970602031037 Basic UDI-DI 06970602031037UDI-DI	Date10 Jul 2024Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference: F2, /

Primary DI / UDI-DI: 06970602031037
Basic UDI-DI: B-06970602031037
EMDN Code: L159004 Endodontic rasps and files, reusable

Device Class: Class IIa
EU market of registration: Denmark

Manufacturer details

EUDAMED SRN: CN-MF-000011715
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Properties

Sterile

Other properties (10)

Implantable: No
Reusable: 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