Root Canal Files

by Shenzhen Superline Technology Co., Ltd. 548 variants

Ref BA1030411CModel K, H, Reamers, C

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69448351ENDO01NS2X Basic UDI-DI 06944835159271UDI-DI	Date29 Apr 2026Registered	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Withdrawn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

Model / Reference: K, H, Reamers, C, BA1030411C

Primary DI / UDI-DI: 06944835159271
Basic UDI-DI: 69448351ENDO01NS2X
Direct Marketing DI: 06944835159271
EMDN Code: L159004 Endodontic rasps and files, reusable

Device Class: Class I
EU market of registration: Ireland

Manufacturer details

EUDAMED SRN: CN-MF-000027059
Authorised representative: Wellkang Ltd XI-AR-000001836

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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