Skip to content

El-B40I

by MICRO-NX Co., Ltd.

Ref EL-B40I

El-B40I is a device classified as Class IIa in the EU and Class I in the US made by Micro-Nx Co., Ltd., registered in EUDAMED on 14 Aug 2023 (Basic UDI-DI B-08800029600098), cleared under FDA 510(k) K201191 on 7 Feb 2022 and listed in FDA GUDID since 30 Jun 2026 (UDI-DI 08800029600098), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201191

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800029600098 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08800029600098 Basic UDI-DI 08800029600098UDI-DIDate14 Aug 2023RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201191 Date7 Feb 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800029600098 registered 14 Aug 2023 Active
  • FDA 510(k) K201191 decided 7 Feb 2022 Active
  • FDA GUDID UDI-DI 08800029600098 listed 30 Jun 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201191
  2. Registered EUDAMED B-08800029600098
  3. Listed FDA GUDID 08800029600098

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Elec-LED
Generic name
Dental surgical power tool motor, electric
Model / reference
EL-B40I
Primary DI / UDI-DI
08800029600098
Basic UDI-DI
B-08800029600098
510(k) Number
FDA product code
EBW
EMDN code
Z12110199 Instruments for dental treatment units - other
GMDN term
Dental surgical power tool motor, electric
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4200
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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.

Manufacturer details

EUDAMED SRN
KR-MF-000026311
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER.

Other devices from Micro-Nx Co., Ltd.

See all devices from Micro-Nx Co., Ltd. →

Properties

  • Sterilise before use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)