V-Onestep

FDA UDI

Class II (US FDA UDI)

by VITROMED GmbH

Identity

Trade Name: V-ONESTEP FDA UDI
Generic Name: IVF medium FDA UDI
Device Name: V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART). FDA UDI
Model / Reference: V-OSM-20 FDA UDI
Description: V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART). FDA UDI

Identifiers

Catalog Number: V-OSM-20 FDA UDI
Primary DI / UDI-DI: 04260650071614 FDA UDI
510(k) Number: K193285 FDA UDI
FDA Product Code: MQL FDA UDI
GMDN Term: IVF medium FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6180 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: IVF medium

V-Onestep by VITROMED GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K193285 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: VITROMED GmbH

Sources (1)

FDA UDI 5c5712be-f667-4487-80d3-d1890b947add 35 fields · synced Jun 6, 2026