Identity
- Trade Name
- Rapid-i Kit EUDAMED
- Device Name
- Rapid-i Kit EUDAMED
- Model / Reference
- 14421 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350025912233 EUDAMED
- Basic UDI-DI
- 735002591AATEG EUDAMED
- 510(k) Number
- K140207 FDA 510(k)
- FDA Product Code
- MQK FDA 510(k)
- EMDN Code
- U08020401 CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6160 FDA 510(k)
- Regulation Number
- 884.6160 FDA 510(k)
- Market of Registration
- Sweden EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Rapid-i Kit is a Labware, Assisted Reproduction device designed for vitrification and warming of oocytes or embryos in assisted reproductive technology (ART). It is a closed-system kit that facilitates rapid cryopreservation by immersing samples in vitrification solution, eliminating the need for traditional slow-freezing techniques.
The kit is supplied as a sterile, single-use disposable system intended for use in clinical settings under aseptic conditions. It is classified as Class II under FDA regulations (product code MQK) and requires compliance with MDR standards in Europe. Storage and handling must adhere to manufacturer guidelines to maintain sterility and ensure proper functionality, with no MRI safety considerations specified.
Frequently asked questions
What is the Rapid-i Kit specifically designed to do in assisted reproductive technology (ART) procedures?
The Rapid-i Kit is designed for vitrification and warming of oocytes (eggs) or embryos, enabling rapid cryopreservation without traditional slow-freezing methods. It uses a closed-system approach to immerse samples in vitrification solution, preserving them efficiently for later use in ART.
Is the Rapid-i Kit intended for single-use or repeated use in clinical settings?
The Rapid-i Kit is explicitly labeled as a sterile, single-use disposable system, meaning each kit is intended for one-time use under aseptic conditions to maintain sterility and functionality.
How should the Rapid-i Kit be stored to ensure proper functionality and sterility?
The kit must be stored and handled according to the manufacturer’s guidelines to preserve sterility and performance. While specific storage conditions aren’t detailed, adherence to aseptic practices is critical due to its single-use, disposable nature.
Are there any special considerations for using the Rapid-i Kit in relation to MRI safety?
The manufacturer does not specify any MRI safety considerations for the Rapid-i Kit, meaning it should not be assumed safe for use in MRI environments unless explicitly confirmed by Vitrolife.
What regulatory pathways has the Rapid-i Kit followed for approval in the U.S. and Europe?
In the U.S., the Rapid-i Kit received FDA clearance through a 510(k) submission, classified as Class II under product code MQK, with a decision described as ‘Substantially Equivalent’ by the Obstetrics/Gynecology advisory committee. In Europe, it complies with MDR (Medical Device Regulation) standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rapid-i™ Kit - Vitrolife, PDF Rapid-i Kit 26851-10 dr2 - Vitrolife, K181461 - Rapid-i™ Kit - Obstetrics & Gynecology, Vitrolife Sweden AB 14422 Rapid-i Kit, Rapid-i Kit - BEUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K140207 | Class II | Active |
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Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (2)
- FDA 510(k) K140207 24 fields · synced Sep 18, 2026
- EUDAMED 2e2ecb4c-af0b-4ec2-886c-bb4c3f8f1711 61 fields · synced Jul 8, 2026