H-Files Flex

by FKG Dentaire Sàrl 32 variants

Ref 01.553.31.035.CG

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number7640142410301029G Basic UDI-DI 07640142435877UDI-DI	Date21 Oct 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Withdrawn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/MDR Active

Specification

EUDAMED

Device Name: Sterile and non sterile reusable hand tools for root canal preparation during endodontic treatment
Model / Reference: 01.553.31.035.CG

Primary DI / UDI-DI: 07640142435877
Basic UDI-DI: 7640142410301029G
EMDN Code: L159004 Endodontic rasps and files, reusable

Device Class: Class I
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CH-MF-000017925
Authorised representative: Emergo Europe B.V. NL-AR-000000116

Other devices from FKG Dentaire Sàrl

Edgetaper Platinum

Class IIa
Edgetaper

Class IIa
Edge Glidepath

Class IIa
Edgeone Fire

Class IIa
Edgeone Glidepath

Class IIa
Edgetaper Platinum

Class IIa

See all devices from FKG Dentaire Sàrl →

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