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Vitrolife 14214

by Next Medical Products, LLC

Ref 14214

Vitrolife 14214 is a device classified as Class I in the EU and Class II in the US made by Next Medical Products, LLC, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 735002591ABUEM) and listed in FDA GUDID since 5 Oct 2020 (UDI-DI 07350025911212), active as of 8 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735002591ABUEM Basic UDI-DI 07350025911212UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350025911212 UDI-DI Date5 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 735002591ABUEM registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI 07350025911212 listed 5 Oct 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350025911212
  2. Registered EUDAMED 735002591ABUEM

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  • Withdrawn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
Ultrasound Transmission Gel EUDAMED
Vitrolife GUDID
Generic name
Topical coupling gel, sterile
Model / reference
14214
Primary DI / UDI-DI
07350025911212
Basic UDI-DI
735002591ABUEM
FDA product code
IYO
EMDN code
Z11040185 Ultrasound scanners - consumables
GMDN term
Topical coupling gel, sterile
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1560
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Topical coupling gel, sterile

Similar devices in this category

Other devices filed under ULTRASOUND SCANNERS - CONSUMABLES.

Other devices from Next Medical Products, LLC

See all devices from Next Medical Products, LLC →

Properties

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