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Sinus Lift SCB401

by Megagen Implant Co. Ltd

Ref SCB401

Sinus Lift SCB401 is a Class I device made by Megagen Implant Co. Ltd, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 880972899187QP) and listed in FDA GUDID since 23 Jun 2015 (UDI-DI 08806388234233), 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 Number880972899187QP Basic UDI-DI 08806388234233UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806388234233 UDI-DI Date23 Jun 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880972899187QP registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 08806388234233 listed 23 Jun 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806388234233
  2. Registered EUDAMED 880972899187QP

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  • Withdrawn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
Sinus Lift
Generic name
Dental implant system
Model / Ref / Catalog
SCB401
Description
Common Cobra Ø4.00
Primary DI / UDI-DI
08806388234233
Basic UDI-DI
880972899187QP
FDA product code
NDP
EMDN code
L150101 Odontostomatology osteotomes, reusable
GMDN term
Dental implant system
Device class
Class I
Regulation number
872.3980
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 · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Dental implant system

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
  • Implantable NoEUDAMEDYesGUDID
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)