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Core Lifter 2 CL02

by Megagen Implant Co. Ltd

Ref CL02

Core Lifter 2 CL02 is a Class I device made by Megagen Implant Co. Ltd, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 880972899177QL) and listed in FDA GUDID since 29 Jun 2021 (UDI-DI 08809728993173), 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 Number880972899177QL Basic UDI-DI 08809728993173UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809728993173 UDI-DI Date29 Jun 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880972899177QL registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 08809728993173 listed 29 Jun 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809728993173
  2. Registered EUDAMED 880972899177QL

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  • Withdrawn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
Core Lifter 2
Generic name
Fixture/appliance dental drill bit, reusable
Model / Ref / Catalog
CL02
Primary DI / UDI-DI
08809728993173
Basic UDI-DI
880972899177QL
FDA product code
EMJ
EMDN code
L150101 Odontostomatology osteotomes, reusable
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY OSTEOTOMES, REUSABLE.

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

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