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VitaVitro ZG-1.0

by Shenzhen Vitavitro Bio-Tech Co., Ltd.

Ref V001001Model ZG-1.0

VitaVitro ZG-1.0 is an assisted reproduction vitrification carrier (EU MDR Class IIa; FDA Class II; FDA product code MQK, Labware, Assisted Reproduction) made by Shenzhen Vitavitro Bio-Tech Co., Ltd., registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI 0697198205ZG1DU), cleared under FDA 510(k) K180073 on 29 Aug 2018 and listed in FDA GUDID since 5 Dec 2018 (UDI-DI 06971982050021), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180073

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0697198205ZG1DU Basic UDI-DI 06971982050021UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06971982050021 UDI-DI Date5 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180073 Date29 Aug 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0697198205ZG1DU registered 16 Sep 2026 Active
  • FDA 510(k) K180073 decided 29 Aug 2018 Active
  • FDA GUDID UDI-DI 06971982050021 listed 5 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180073
  2. Listed FDA GUDID 06971982050021
  3. Registered EUDAMED 0697198205ZG1DU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
VitaVitro Straw Set EUDAMED
VitaVitro GUDID
Generic name
Assisted reproduction vitrification carrier
Model / reference
ZG-1.0, V001001
Primary DI / UDI-DI
06971982050021
Basic UDI-DI
0697198205ZG1DU
510(k) Number
FDA product code
MQK
EMDN code
U08020401 Cryopreservation containers/straws/vials for assisted reproduction
GMDN term
Assisted reproduction vitrification carrier
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.6160
EU registration type
Standard device
EU market of registration
Italy
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: Assisted reproduction vitrification carrier

Cleared under the same submission (K180073)

Similar devices in this category

Other devices filed under CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION.

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

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

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
Other properties (22, all answered No)