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Ratchet Handle THTH0810

by Megagen Implant Co. Ltd EUDAMEDGUDID

Active European Union

Ref THTH0810

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899002B Basic UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809985667756 UDI-DIDate9 May 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  • Withdrawn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 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Ratchet Handle
Generic Name
Fixture/appliance dental drill bit, reusable
Device Name
Surgical Instruments
Model / Ref / Catalog
THTH0810
Primary DI / UDI-DI
08809985667756
Basic UDI-DI
880972899002B
FDA Product Code
NDP
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Fixture/appliance dental drill bit, 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

Related devices

Category: Fixture/appliance dental drill bit, reusable

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