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i-Clean Ratchet Driver DRMDIL

by Dentis Co., Ltd

Ref DRMDIL

i-Clean Ratchet Driver DRMDIL is a device classified as Class IIa in the EU and Class I in the US made by Dentis Co., Ltd, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-08806169138989) and listed in FDA GUDID since 31 May 2021 (UDI-DI 08806169138989), active as of 23 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-08806169138989 Basic UDI-DI 08806169138989UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806169138989 UDI-DI Date31 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806169138989 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 08806169138989 listed 31 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806169138989
  2. Registered EUDAMED B-08806169138989

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
i-Clean Ratchet Driver
Generic name
Surgical screwdriver, reusable
Model / reference
DRMDIL
Primary DI / UDI-DI
08806169138989
Basic UDI-DI
B-08806169138989
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Surgical screwdriver, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Dentis Co., Ltd

See all devices from Dentis Co., Ltd →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)