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Surgical Kit Kche 04

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

Ref KCHE 04Model NON-STERILE SURGICAL INSTRUMENTS

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000062K4 Basic UDI-DI 07899995293565UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995293565 UDI-DI Date31 Mar 2021ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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 Surgical Tryon EUDAMED
Surgical Kit GUDID
Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
KCHE 04, NON-STERILE SURGICAL INSTRUMENTS
Primary DI / UDI-DI
07899995293565
Basic UDI-DI
999520000062K4
510(k) Number
FDA Product Code
KCT
EMDN Code
L159099 Odontostomatology instruments, reusable - other
GMDN Term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.6850
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K201688)

Show all (12)

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

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Properties

  • Reusable
  • Reprocessed
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No