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i-Clean Ratchet Driver DRMDIS

by Dentis Co., Ltd

Ref DRMDIEL, DRMDISModel DENTIS Implant Surgical Instrument System

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

CE MDR CE MDD

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/MDD EUDAMED Number88061691DENTIS-I7L Basic UDI-DI Date27 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number88061691DENTIS-I7L Basic UDI-DI Date27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806169138972 UDI-DI Date31 May 2021ListedStatusListed 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  • Withdrawn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/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
i-Clean Ratchet Driver
Generic Name
Surgical screwdriver, reusable
Device Name
DENTIS Implant Surgical Instrument System
Model / Reference
DRMDIS, DENTIS Implant Surgical Instrument System, DRMDIEL
Primary DI / UDI-DI
08806169138972, 08806169138996
Basic UDI-DI
88061691DENTIS-I7L, B-08806169138972
FDA Product Code
NDP
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Surgical screwdriver, reusable
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Regulation Number
872.3980
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class I

Related devices

Category: Surgical screwdriver, reusable

Other devices from Dentis Co., Ltd

See all devices from Dentis Co., Ltd →

Properties

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

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Serial Number: No
  • Expiration Date: No