# VitaVitro ZG-1.0

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/vitavitro-zg-1-0>
- Manufacturer: [Shenzhen Vitavitro Bio-Tech Co., Ltd.](https://devicerts.com/manufacturers/shenzhen-vitavitro-bio-tech-co-ltd) (China, FDA 510(k) applicant)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: MQK, MQL
- EMDN: U08020401 CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION
- GMDN: Assisted reproduction vitrification carrier (47446)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 0697198205ZG1DU · UDI-DI 06971982050021 · registered 2026-09-16 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 06971982050021 · listed 2018-12-05 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K180073 · decision 2018-08-29 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: VitaVitro Straw Set [EUDAMED]; VitaVitro [FDA GUDID (AccessGUDID)]
- Generic name: Assisted reproduction vitrification carrier [FDA GUDID (AccessGUDID)]
- Model / reference: ZG-1.0 [EUDAMED, FDA GUDID (AccessGUDID)]; V001001 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 06971982050021 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 0697198205ZG1DU [EUDAMED]
- 510(k) Number: K180073 [FDA GUDID (AccessGUDID)]
- FDA product code: MQK [FDA GUDID (AccessGUDID)]
- EMDN code: U08020401 [EUDAMED]
- GMDN term: Assisted reproduction vitrification carrier (47446) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 884.6160 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Italy [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: VitaVitro ZG-1.0, Shenzhen Vitavitro Bio-Tech Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/vitavitro-zg-1-0 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/vitavitro-zg-1-0.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/vitavitro-zg-1-0
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.