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Direction Indicator MDI1618

by Megagen Implant Co. Ltd

Ref CMDI2529, MDI1618

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899022F Basic UDI-DI Date24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806388297238 UDI-DI Date29 Nov 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Direction Indicator
Generic Name
Dental implant system
Fixture/appliance dental drill bit, reusable
Device Name
Guides
Model / Ref / Catalog
MDI1618, CMDI2529
Primary DI / UDI-DI
08806388297238, 08809931181572
Basic UDI-DI
880972899022F
FDA Product Code
NDP
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Dental implant system
Fixture/appliance dental drill bit, reusable
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
No
Yes

Related devices

Category: Dental implant system

Other devices from Megagen Implant Co., Ltd.

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

Properties

  • Single Use NoGUDIDYesGUDID
  • Implantable NoEUDAMEDGUDIDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No