Unitron

FDA UDI

Class II (US FDA UDI)

by Unitron Hearing

Identity

Trade Name: Unitron FDA UDI
Generic Name: Spermatozoa/semen analyser IVD FDA UDI
Device Name: Unitron Remote RCV1 Packaged FDA UDI
Model / Reference: 076-5014-00001 FDA UDI
Description: Unitron Remote RCV1 Packaged FDA UDI

Identifiers

Catalog Number: 076-5014-00001 FDA UDI
Primary DI / UDI-DI: 00698764424769 FDA UDI
FDA Product Code: OSM FDA UDI
GMDN Term: Spermatozoa/semen analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3305 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Spermatozoa/semen analyser IVD

Unitron by Unitron Hearing — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Spermatozoa/semen analyser IVD.

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SQA-iOw Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II
LensHooke Semen Analysis System — BONRAYBIO CO., LTD. · Class II
LensHooke Semen Quality Analyzer — BONRAYBIO CO., LTD. · Class II
SQA-V Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II
LensHooke Semen Quality Analyzer — BONRAYBIO CO., LTD. · Class II
LensHooke Semen Analysis System — BONRAYBIO CO., LTD. · 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 II	Pending data

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Manufacturer

Manufacturer: Unitron Hearing

Sources (1)

FDA UDI 489dffd8-a2a3-4fec-ab93-c06923160f37 35 fields · synced Jun 8, 2026