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Milex MXPRSK13

by CooperSurgical, Inc.

Ref MXPRSK13Model MXPCON00

Milex MXPRSK13 is a device classified as Class IIb in the EU and Class II in the US made by CooperSurgical, Inc., registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 0888937TD08222) and listed in FDA GUDID since 26 Jul 2016 (UDI-DI 00888937008937), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888937TD08222 Basic UDI-DI 00888937008937UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888937008937 UDI-DI Date26 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888937TD08222 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00888937008937 listed 26 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888937008937
  2. Registered EUDAMED 0888937TD08222

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Milex™ EUDAMED
Milex GUDID
Generic name
Pelvic-organ-supporting pessary
Device name
Milex™ Incontinence Dish and Ring Pessaries
Model / reference
MXPRSK13, MXPCON00
Primary DI / UDI-DI
00888937008937
Basic UDI-DI
0888937TD08222
FDA product code
HHW
EMDN code
U089005 Pessarians
GMDN term
Pelvic-organ-supporting pessary
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
884.3575
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Pelvic-organ-supporting pessary

Similar devices in this category

Other devices filed under PESSARIANS.

Other devices from CooperSurgical, Inc.

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)