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Gx-TL 10172

by Vitrolife Sweden AB

Ref 10172

Gx-TL 10172 is an IVF medium (EU MDR Class III; FDA Class II; FDA product code MQL, Media, Reproductive) made by Vitrolife Sweden AB, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 735002591AAQEA) and listed in FDA GUDID since 21 May 2021 (UDI-DI 07350025910611), active as of 7 Nov 2026.

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

CE MDR

Valid until

21 Sep 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier DNV Product Assurance AS

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735002591AAQEA Basic UDI-DI 07350025910611UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350025910611 UDI-DI Date21 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 735002591AAQEA registered 1 Jul 2026 Active
  • FDA GUDID UDI-DI 07350025910611 listed 21 May 2021 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • C597140 Active

    Quality management system EU MDR

    Certifier
    DNV Product Assurance AS 2460
    Issued
    22 Sep 2023
    Expires
    21 Sep 2028
  • C597141 Active

    Technical documentation EU MDR

    Certifier
    DNV Product Assurance AS 2460
    Issued
    22 Sep 2023
    Expires
    21 Sep 2028

Timeline

2 dated events

  1. Listed FDA GUDID 07350025910611
  2. Registered EUDAMED 735002591AAQEA

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  • Withdrawn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
Gx-TL
Generic name
IVF medium
Model / reference
10172
Primary DI / UDI-DI
07350025910611
Basic UDI-DI
735002591AAQEA
FDA product code
MQL
EMDN code
U08020503 Materials/culture media for assisted reproduction
GMDN term
IVF medium
Device class
Class III EUDAMED
Class II GUDID
Regulation number
884.6180
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

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/CULTURE MEDIA FOR ASSISTED REPRODUCTION.

Other devices from Vitrolife Sweden AB

See all devices from Vitrolife Sweden AB →

Properties

  • Supplied sterile
  • Single use
  • Incorporates a substance derived from human blood or plasma
  • Incorporates a medicinal substance
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)