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Ovoil 10029

by Vitrolife Sweden AB

Ref 10029

Ovoil 10029 is a device classified as Class IIa in the EU and Class II in the US made by Vitrolife Sweden AB, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 735002591AAOE6) and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 07350025910307), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735002591AAOE6 Basic UDI-DI 07350025910307UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350025910307 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 735002591AAOE6 registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI 07350025910307 listed 13 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350025910307
  2. Registered EUDAMED 735002591AAOE6

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  • Withdrawn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
Ovoil
Generic name
IVF medium
Device name
Overlay oil
Model / reference
10029
Primary DI / UDI-DI
07350025910307
Basic UDI-DI
735002591AAOE6
FDA product code
QKI
EMDN code
U08020502 Materials/solutions for preparation/handling for assisted reproduction
GMDN term
IVF medium
Device class
Class IIa 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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 Vitrolife Sweden AB

See all devices from Vitrolife Sweden AB →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)