# Cryolock

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

- Canonical page: <https://devicerts.com/devices/cryolock-cl-r-ct>
- Manufacturer: [Biotech Inc](https://devicerts.com/manufacturers/biotech-inc) (United States)
- Name in the registry: CRYOLOCK
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: MQK
- 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 \++B056CRYOLOCKFAMILYDEVW8 · UDI-DI \+B056CLRCT · registered 2022-10-28 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI \+B056CLRCT · listed 2016-12-13 · status: Listed (GUDID: not in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K122982 · issued 2014-01-09 · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Assisted reproduction vitrification carrier [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: CL-R-CT [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: \+B056CLRCT [EUDAMED]; B056CLRCT1 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: \++B056CRYOLOCKFAMILYDEVW8 [EUDAMED]
- Unit of use DI: 1 [EUDAMED]
- 510(k) Number: K122982 [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: Netherlands [EUDAMED]
- GUDID distribution status: Not in Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Radiation Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [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]
- 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Cryolock, Biotech Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/cryolock-cl-r-ct (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/cryolock-cl-r-ct.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/cryolock-cl-r-ct
- 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.