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Mammorep Loop Mlx

by Sterylab SRL 4 variants

Part of a family of 73 devices: see the family page

Ref MLX2009

Mammorep Loop Mlx (MLX2009) is a device classified as Class IIa in the EU and Class II in the US made by Sterylab SRL, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 803395922MAMMOREP7R), cleared under FDA 510(k) K051506 on 27 Jul 2005 and listed in FDA GUDID since 3 Oct 2019 (UDI-DI 08033959221877), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K051506

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803395922MAMMOREP7R Basic UDI-DI 08033959221877UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033959221877 UDI-DI Date3 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK051506 Date27 Jul 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803395922MAMMOREP7R registered 28 Oct 2026 Active
  • FDA 510(k) K051506 decided 27 Jul 2005 Active
  • FDA GUDID UDI-DI 08033959221877 listed 3 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K051506
  2. Listed FDA GUDID 08033959221877
  3. Registered EUDAMED 803395922MAMMOREP7R

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  • Withdrawn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
Mammorep Loop EUDAMED
Mammorep Loop Mlx GUDID
Generic name
Soft-tissue biopsy procedure kit, non-medicated
Device name
Dispositivi per Reperaggio Mammario
Model / Ref / Catalog
MLX2009, MAMMOREP LOOP MLX
Primary DI / UDI-DI
08033959221877
Basic UDI-DI
803395922MAMMOREP7R
510(k) Number
FDA product code
KNW, FCG
EMDN code
A019012 Breast nodules and other structures localisation needles and systems
GMDN term
Soft-tissue biopsy procedure kit, non-medicated
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MLX2009
GUDID
MAMMOREP LOOP MLX
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Soft-tissue biopsy procedure kit, non-medicated

Cleared under the same submission (K051506)

and 8 more cleared under K051506

Similar devices in this category

Other devices filed under BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS.

Other devices from Sterylab SRL

  • Mammorep Zeta

    Class II

  • Complete-Chiba

    Class II

  • Ata-Cut

    Class II

  • Complete-Chiba MR

    Class II

See all devices from Sterylab SRL →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)