Skip to content

K3 Eng File

by Kerr Italia SRL 49 variants

Ref 825-2305, 825-2405, 825-6551, 825-4600, 825-4201, 825-4025, 825-6255, 825-4605, 825-2351, 825-2350, 825-4601, 825-6351, 825-4021, 825-2400, 825-2250, 830-8257, 825-4500, 825-4555, 825-2301, 830-7725, 830-2257, 825-6600, 825-2151, 830-0257, 825-2205, 825-6305, 825-6021, 830-2255, 825-2300, 825-2251, 830-9921, 825-6605, 825-2201, 825-4151, 825-4255, 825-6401, 825-6451, 825-6301, 830-0255, 830-0421, 825-4551, 825-4451, 825-6151, 825-6300, 830-8255, 825-2200, 825-4450, 825-4301, 825-4305, 825-2150, 830-0625

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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80515118720000105C Basic UDI-DI Date25 Mar 2026RegisteredStatusActive

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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
825-2305, 825-2405, 825-6551, 825-4600, 825-4201, 825-4025, 825-6255, 825-4605, 825-2351, 825-2350, 825-4601, 825-6351, 825-4021, 825-2400, 825-2250, 830-8257, 825-4500, 825-4555, 825-2301, 830-7725, 830-2257, 825-6600, 825-2151, 830-0257, 825-2205, 825-6305, 825-6021, 830-2255, 825-2300, 825-2251, 830-9921, 825-6605, 825-2201, 825-4151, 825-4255, 825-6401, 825-6451, 825-6301, 830-0255, 830-0421, 825-4551, 825-4451, 825-6151, 825-6300, 830-8255, 825-2200, 825-4450, 825-4301, 825-4305, 825-2150, 830-0625
Primary DI / UDI-DI
08055165087436, 08055165087603, 08055165087672, 08055165087726, 08055165086934, 08055165086897, 08055165086804, 08055165087481, 08055165087689, 08055165087795, 08055165087702, 08055165087269, 08055165087344, 08055165087818, 08055165087719, 08055165086958, 08055165087610, 08055165087498, 08055165087511, 08055165087221, 08055165086880, 08055165087634, 08055165087313, 08055165086873, 08055165087450, 08055165086859, 08055165087047, 08055165087320, 08055165087771, 08055165087429, 08055165087078, 08055165087412, 08055165087559, 08055165086910, 08055165086798, 08055165087214, 08055165087528, 08055165087054, 08055165087085, 08055165087245, 08055165087764, 08055165087504, 08055165086972, 08055165087283, 08055165087092, 08055165087573, 08055165087566, 08055165087030, 08055165086828, 08055165087641, 08055165087153
Basic UDI-DI
80515118720000105C
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007768

Other devices from Kerr Italia SRL

See all devices from Kerr Italia SRL →

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