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Multi-Unit-Detector Set ZBBDMDNO3045TC

by Megagen Implant Co. Ltd EUDAMEDGUDID

Active European Union

Ref ZBBDMDNO1745TC, ZBBDMDNO3045TC

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899022F Basic UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800293000211 UDI-DIDate3 Feb 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Multi-Unit-Detector Set
Generic Name
Surgical screwdriver, reusable
Device Name
Guides
Model / Ref / Catalog
ZBBDMDNO3045TC, ZBBDMDNO1745TC
Primary DI / UDI-DI
08800293000211, 08800293000204
Basic UDI-DI
880972899022F
FDA Product Code
NDP
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Surgical screwdriver, reusable
Device Class
Class I
Regulation Number
872.3980
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Megagen Implant Co., Ltd.

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

Properties

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

Other properties (18)

  • Sterile: No
  • Implantable: 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