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Macroplastique Implants MPQ-2.5

by Uroplasty, LLC

Ref MPQ-2.5Model MPQ – 2.5 cc syringe

Macroplastique Implants MPQ-2.5 is a device classified as Class IIb in the EU and Class III in the US made by Uroplasty, LLC, registered in EUDAMED on 28 May 2026 (Basic UDI-DI B-08717591240013), approved under FDA PMA P040050 on 30 Oct 2006 and listed in FDA GUDID since 20 Jun 2014 (UDI-DI 08717591240013), active as of 25 Oct 2026.

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

CE MDD PMA

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P040050

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08717591240013 Basic UDI-DI 08717591240013UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717591240013 UDI-DI Date20 Jun 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP040050 Date30 Oct 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08717591240013 registered 28 May 2026 Active
  • FDA PMA P040050 decided 30 Oct 2006 Active
  • FDA GUDID UDI-DI 08717591240013 listed 20 Jun 2014 Listed

Timeline

3 dated events

  1. Approved FDA PMA P040050
  2. Listed FDA GUDID 08717591240013
  3. Registered EUDAMED B-08717591240013

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Macroplastique Implants, 2.5 cc syringe fill, 3.0 cc polycarbonate syringe EUDAMED
Macroplastique Implants GUDID
Generic name
Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
Model / Ref / Catalog
MPQ-2.5, MPQ – 2.5 cc syringe
Primary DI / UDI-DI
08717591240013 EUDAMED
08717591240266 GUDID
Basic UDI-DI
B-08717591240013
PMA number
FDA product code
LNM
EMDN code
P900403 Non-resorbable filling and reconstruction devices
GMDN term
Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
Device class
Class IIb EUDAMED
Class III GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08717591240013
GUDID
08717591240266
Device classEUDAMED
Class IIb
GUDID
Class III

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08717591240013; FDA GUDID lists 08717591240266), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

Similar devices in this category

Other devices filed under NON-RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from Uroplasty, LLC

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)