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MEDENTiKA 0-13-83

by MEDENTiKA GmbH EUDAMEDGUDID

Active European Union

Ref 0-13-83Model Surgical tray

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42515748SUT004MM Basic UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04251574800541 UDI-DIDate20 Dec 2020ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MEDENTiKA
Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
0-13-83, Surgical tray
Primary DI / UDI-DI
04251574800541
Basic UDI-DI
42515748SUT004MM
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
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

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

Other devices from MEDENTiKA GmbH

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Properties

  • Reusable
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No