Skip to content

PureCeption 40% Upper Phase ART-2040

by CooperSurgical, Inc.

Ref ART-2040

PureCeption 40% Upper Phase ART-2040 is an IVF medium (EU MDD Class III; FDA Class II; FDA product code MQL, Media, Reproductive) made by CooperSurgical, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-00888937818611) and listed in FDA GUDID since 28 Jul 2016 (UDI-DI 00888937818611), active as of 23 Oct 2026.

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

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00888937818611 Basic UDI-DI 00888937818611UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888937818611 UDI-DI Date28 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00888937818611 registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 00888937818611 listed 28 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888937818611
  2. Registered EUDAMED B-00888937818611

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
PureCeption™ 40% Upper Phase EUDAMED
PureCeption 40% Upper Phase GUDID
Generic name
IVF medium
Model / reference
ART-2040
Primary DI / UDI-DI
00888937818611 EUDAMED
00888937818628 GUDID
Basic UDI-DI
B-00888937818611
FDA product code
MQL
EMDN code
U08020502 Materials/solutions for preparation/handling for assisted reproduction
GMDN term
IVF medium
Device class
Class III EUDAMED
Class II GUDID
Regulation number
884.6180
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
00888937818611
GUDID
00888937818628
Device classEUDAMED
Class III
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00888937818611; FDA GUDID lists 00888937818628), so their flags are not compared. Device class is stated on each registry's own scale: Class III 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: IVF medium

Similar devices in this category

Other devices filed under MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Supplied sterile
  • Contains animal tissues or cells
  • Incorporates a medicinal substance
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)