Prerace

by FKG Dentaire Sàrl 10 variants

Ref S1.7B0.00.0DB.FK

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-07640142413318 Basic UDI-DI 07640142413318UDI-DI	Date17 Mar 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Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference: S1.7B0.00.0DB.FK

Primary DI / UDI-DI: 07640142413318
Basic UDI-DI: B-07640142413318
EMDN Code: L159004 Endodontic rasps and files, reusable

Device Class: Class IIa
EU market of registration: Germany

Manufacturer details

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

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Properties

Sterile
Reusable

Other properties (9)

Implantable: 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