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Zenex Superwide Kit

by Izenimplant Co., Ltd

Ref ZENSWKIT

Zenex Superwide Kit (ZENSWKIT) is a device classified as Class IIa in the EU and Class I in the US made by Izenimplant Co., Ltd, registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI B-08800070218549) and listed in FDA GUDID since 20 May 2022 (UDI-DI 08800070218549), active as of 22 Oct 2026.

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

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800070218549 Basic UDI-DI 08800070218549UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800070218549 UDI-DI Date20 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800070218549 registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 08800070218549 listed 20 May 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800070218549
  2. Registered EUDAMED B-08800070218549

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / reference
ZENSWKIT
Primary DI / UDI-DI
08800070218549
Basic UDI-DI
B-08800070218549
FDA product code
NDP
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
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.

Manufacturer details

EUDAMED SRN
KR-MF-000026205
Authorised representative
KTR Europe GmbH DE-AR-000005685

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Izenimplant Co., Ltd

See all devices from Izenimplant Co., Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)