Skip to content

Euromi 1214LILI-4200

by Euromi

Ref 1214LILI-4200

Euromi 1214LILI-4200 is a device classified as Class IIa in the EU and Class I in the US made by Euromi, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 3701416250000CAN3G), cleared under FDA 510(k) K010311 on 29 Jun 2001 and listed in FDA GUDID since 10 Oct 2025 (UDI-DI 03701416202343), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K010311

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3701416250000CAN3G Basic UDI-DI 03701416202343UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701416202343 UDI-DI Date10 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK010311 Date29 Jun 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3701416250000CAN3G registered 20 May 2026 Active
  • FDA 510(k) K010311 decided 29 Jun 2001 Active
  • FDA GUDID UDI-DI 03701416202343 listed 10 Oct 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K010311
  2. Listed FDA GUDID 03701416202343
  3. Registered EUDAMED 3701416250000CAN3G

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Euromi
Generic name
Liposuction system cannula, reusable
Device name
Canules réutilisables / Reusable cannulas
Model / Ref / Catalog
1214LILI-4200
Primary DI / UDI-DI
03701416202343
Basic UDI-DI
3701416250000CAN3G
510(k) Number
FDA product code
GEA
EMDN code
L250301 Liposuction cannulas, reusable
GMDN term
Liposuction system cannula, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Belgium
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

Cleared under the same submission (K010311)

and 3 more cleared under K010311

Other devices from Euromi

See all devices from Euromi →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)