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Kit Replacement Drills Epikut Krfe

by S.I.N. - Sistema DE Implante Nacional S.A.

Ref KRFEModel INSTRUMENTS CLASS IIa - KIT

Kit Replacement Drills Epikut Krfe is a device classified as Class IIa in the EU and Class I in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 999520000082KA) and listed in FDA GUDID since 7 Nov 2025 (UDI-DI 07899995251404), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000082KA Basic UDI-DI 07899995251404UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995251404 UDI-DI Date7 Nov 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 999520000082KA registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 07899995251404 listed 7 Nov 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899995251404
  2. Registered EUDAMED 999520000082KA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Kit Replacement Drill Epikut EUDAMED
Kit Replacement Drills Epikut GUDID
Generic name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device name
Kit Epikut
Model / Ref / Catalog
KRFE, INSTRUMENTS CLASS IIa - KIT
Primary DI / UDI-DI
07899995251404
Basic UDI-DI
999520000082KA
FDA product code
NDP
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from S.I.N. - Sistema DE Implante Nacional S.A.

See all devices from S.I.N. - Sistema DE Implante Nacional S.A. →

Properties

  • Sterilise before use
  • Reusable
  • Reprocessed single-use device
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)