Nidacon

FDA UDI

Class I (US FDA UDI)

by Nidacon International AB

Identity

Trade Name: Nidacon FDA UDI
Generic Name: Spermatozoa/semen motility medium supplement FDA UDI
Device Name: An optimized staining technique for assessment of sperm vitality. For use with Assisted Reproduction Technology (ART) FDA UDI
Model / Reference: SpermVitalStain FDA UDI
Description: An optimized staining technique for assessment of sperm vitality. For use with Assisted Reproduction Technology (ART) FDA UDI

Identifiers

Catalog Number: SVS-010 FDA UDI
Primary DI / UDI-DI: 07350025610191 FDA UDI
FDA Product Code: KKD FDA UDI
HYB FDA UDI
MQL FDA UDI
GMDN Term: Spermatozoa/semen motility medium supplement FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1850 FDA UDI
884.6180 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Spermatozoa/semen motility medium supplement

Nidacon by Nidacon International AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Spermatozoa/semen motility medium supplement.

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Enhance-S Plus — Vitrolife AB · Class II
Enhance Sperm Wash w/ Gentamicin — Vitrolife AB · Class II
Enhance-S Plus — Vitrolife AB · Class II
Enhance-S Plus — Vitrolife AB · Class II
SpermSelect Curve Kit — CooperSurgical, Inc. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Nidacon International AB

Sources (1)

FDA UDI 8639a6de-a8b2-457d-9986-70e9cad67d9c 36 fields · synced Jun 1, 2026