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Ise-270M

by MICRO-NX Co., Ltd.

Ref ISE-270M

Ise-270M 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 7 Apr 2026 (Basic UDI-DI B-08800029600616), cleared under FDA 510(k) K201192 on 21 May 2021 and listed in FDA GUDID since 30 Jun 2026 (UDI-DI 08800029600616), 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) K201192

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 Number08800029600616 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08800029600616 Basic UDI-DI 08800029600616UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201192 Date21 May 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800029600616 registered 7 Apr 2026 Active
  • FDA 510(k) K201192 decided 21 May 2021 Active
  • FDA GUDID UDI-DI 08800029600616 listed 30 Jun 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201192
  2. Registered EUDAMED B-08800029600616
  3. Listed FDA GUDID 08800029600616

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  • Withdrawn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
Impla-NX (Model: ISE-270M)
Generic name
Dental surgical power tool motor, electric
Model / reference
ISE-270M
Primary DI / UDI-DI
08800029600616
Basic UDI-DI
B-08800029600616
510(k) Number
FDA product code
EBW
EMDN code
Q010399 Surgical dental devices - 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 SURGICAL DENTAL DEVICES - 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)