Skip to content

VitriFreeze VF_KIT1

by Fertipro NV

VitriFreeze VF_KIT1 is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by Fertipro NV, cleared under FDA 510(k) K070135 on 16 Aug 2007 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05411967001415), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K070135

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05411967001415 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070135 Date16 Aug 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070135 decided 16 Aug 2007 Active
  • FDA GUDID UDI-DI 05411967001415 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070135
  2. Listed FDA GUDID 05411967001415

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VitriFreeze
Generic name
IVF medium
Model / reference
VF_KIT1
Primary DI / UDI-DI
05411967001415
510(k) Number
FDA product code
MQL
GMDN term
IVF medium
Device class
Class II
Regulation number
884.6180
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under IVF medium.

Other devices from Fertipro NV

  • VitriFreeze VF1001

    Class II
  • VitriFreeze VPI005

    Class II
  • VitriThaw VT3001

    Class II
  • VitriFreeze VF2001

    Class II

See all devices from Fertipro NV →

Properties

  • Supplied sterile
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)