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VitaVitro Sperm Gradient Medium SG-80, 12 mL

by Shenzhen Vitavitro Bio-Tech Co., Ltd.

VitaVitro Sperm Gradient Medium SG-80, 12 mL (V01501280) is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by Shenzhen Vitavitro Bio-Tech Co., Ltd., cleared under FDA 510(k) K212410 on 1 Feb 2022 and listed in FDA GUDID since 11 Feb 2022 (UDI-DI 06971982050144), active as of 22 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 22 Oct 2026

Documents

510(k) K212410

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06971982050144 UDI-DI Date11 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212410 Date1 Feb 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212410 decided 1 Feb 2022 Active
  • FDA GUDID UDI-DI 06971982050144 listed 11 Feb 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212410
  2. Listed FDA GUDID 06971982050144

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VitaVitro
Generic name
IVF medium
Model / Ref / Catalog
Sperm Gradient Medium SG-80, 12 mL, V01501280
Primary DI / UDI-DI
06971982050144
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

Related devices

Category: IVF medium

Cleared under the same submission (K212410)

and 7 more cleared under K212410

Similar devices in this category

Other devices filed under IVF medium.

Other devices from Shenzhen Vitavitro Bio-Tech Co., Ltd.

See all devices from Shenzhen Vitavitro Bio-Tech Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)