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LiteSet™ 302535

by Nobel Biocare AB

Part of a family of 11 devices: see the family page

Ref 302535

LiteSet™ 302535 is a device classified as Class I in the EU and Class II in the US made by Nobel Biocare AB, cleared under FDA 510(k) K253988 on 8 Sep 2026, registered in EUDAMED on 23 Apr 2026 (Basic UDI-DI 733274700000022472) and listed in FDA GUDID since 11 Sep 2026 (UDI-DI 07332747224832), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253988

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07332747224832 UDI-DI Date11 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK253988 Date8 Sep 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number733274700000022472 Basic UDI-DI 07332747224832UDI-DIDate23 Apr 2026RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K253988 decided 8 Sep 2026 Active
  • EUDAMED Basic UDI-DI 733274700000022472 registered 23 Apr 2026 Active
  • FDA GUDID UDI-DI 07332747224832 listed 11 Sep 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED 733274700000022472
  2. Cleared FDA 510(k) K253988
  3. Listed FDA GUDID 07332747224832

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
NobelReplace® S LiteSet™ Tray EUDAMED
LiteSet™ GUDID
Generic name
Instrument tray, reusable
Device name
Sterilization trays and plates
Model / Ref / Catalog
302535
Primary DI / UDI-DI
07332747224832
Basic UDI-DI
733274700000022472
Direct marketing DI
07332747224832
510(k) Number
FDA product code
KCT
EMDN code
S0199 Devices for sterilisation and packaging (excluding cat. d - z) - 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
Sweden
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 I
GUDID
Class II

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

Cleared under the same submission (K253988)

Similar devices in this category

Other devices filed under DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER.

Other devices from Nobel Biocare AB

See all devices from Nobel Biocare AB →

Properties

  • Sterilise before use
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)