ZyMot

FDA UDI

Class II (US FDA UDI)

by Dxnow, Inc.

Identity

Trade Name: ZyMot FDA UDI
Generic Name: Assisted reproduction microtool FDA UDI
Device Name: Sperm Separation Device FDA UDI
Model / Reference: Multi 850 microL FDA UDI
Description: Sperm Separation Device FDA UDI

Identifiers

Catalog Number: ZMH0850 FDA UDI
Primary DI / UDI-DI: 00860451001212 FDA UDI
510(k) Number: K173075 FDA UDI
FDA Product Code: MQK FDA UDI
GMDN Term: Assisted reproduction microtool FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6160 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: Assisted reproduction microtool

ZyMot by Dxnow, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K173075 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: Dxnow, Inc.

Sources (1)

FDA UDI 89abb796-4c29-4a42-b13d-3ae313574b8e 35 fields · synced May 31, 2026