Root Canal File

by Chengdu Sani Medical Equipment Co., Ltd. 347 variants

Model K Files 21mm 06

Active European Union

CE MDR

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/MDR	Number697060203RCF0016T Basic UDI-DI 06970602032102UDI-DI	Date8 Aug 2022Registered	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Withdrawn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/MDR Active

Specification

EUDAMED

Device Name: Root Canal File
Model / Reference: K Files 21mm 06

Primary DI / UDI-DI: 06970602032102
Basic UDI-DI: 697060203RCF0016T
EMDN Code: L159004 Endodontic rasps and files, reusable

Device Class: Class I
EU market of registration: Cyprus

Manufacturer details

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

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Root Canal File

Class I
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Class IIa
Root Canal File

Class I
Rotary Endo File

Class IIa

See all devices from Chengdu Sani Medical Equipment Co., Ltd →

Properties

Reusable

Other properties (12)

Sterile: No
Implantable: 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