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DIO Master Kit UF 06<VerD>

by DIO Corporation

Ref UF 06

DIO Master Kit UF 06<VerD> is a device classified as Class IIa in the EU and Class I in the US made by DIO Corporation, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 880004924002AT) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 08800049427705), 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 Number880004924002AT Basic UDI-DI 08800049427705UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800049427705 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880004924002AT registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 08800049427705 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800049427705
  2. Registered EUDAMED 880004924002AT

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  • Withdrawn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
DIO Master Kit
Generic name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / reference
UF 06 EUDAMED
UF 06<VerD> GUDID
Primary DI / UDI-DI
08800049427705
Basic UDI-DI
880004924002AT
FDA product code
OFY
EMDN code
L159016 Dental surgery instrument kits, reusable
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
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
UF 06
GUDID
UF 06<VerD>
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.

Related devices

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

Similar devices in this category

Other devices filed under DENTAL SURGERY INSTRUMENT KITS, REUSABLE.

Other devices from DIO Corporation

See all devices from DIO Corporation →

Properties

  • Sterilise before use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)