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Neodent 110.337

by JJGC Indústria e Comércio de Materiais Dentários S/A.

Ref 110.337Model Instrument

Neodent 110.337 is a device classified as Class I in the EU and Class II in the US made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 987800001UZ) and listed in FDA GUDID since 19 Sep 2024 (UDI-DI 07899878064640), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number987800001UZ Basic UDI-DI 07899878064640UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899878064640 UDI-DI Date19 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 987800001UZ registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 07899878064640 listed 19 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899878064640
  2. Registered EUDAMED 987800001UZ

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  • Withdrawn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
Neodent
Generic name
Instrument tray, reusable
Device name
Kit Case
Model / Ref / Catalog
110.337, Instrument
Primary DI / UDI-DI
07899878064640
Basic UDI-DI
987800001UZ
FDA product code
KCT
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Instrument tray, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Height — 49 Millimeter
Length — 195 Millimeter
Width — 90 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07899878064640: EUDAMED states No, FDA GUDID states Yes.

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

Related devices

Category: Instrument tray, reusable

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - OTHER.

Other devices from JJGC Indústria e Comércio de Materiais Dentários S/A.

See all devices from JJGC Indústria e Comércio de Materiais Dentários S/A. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Reusable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)