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SQA-iOw Sperm Quality Analyzer

FDA UDI

Class II (US FDA UDI)

by M.e.s. Medical Electronic Systems Ltd.

Identity

Trade Name
SQA-iOw Sperm Quality Analyzer FDA UDI
Generic Name
Spermatozoa/semen analyser IVD FDA UDI
Model / Reference
SQA-iOw Sperm Quality Analyzer FDA UDI

Identifiers

Primary DI / UDI-DI
07290016650822 FDA UDI
510(k) Number
K243114 FDA UDI
FDA Product Code
POV FDA UDI
GMDN Term
Spermatozoa/semen analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Spermatozoa/semen analyser IVD

SQA-iOw Sperm Quality Analyzer by M.e.s. Medical Electronic Systems Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spermatozoa/semen analyser IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
M.e.s. Medical Electronic Systems Ltd.

Sources (1)

  • FDA UDI 1e949fb5-453b-48c9-9b48-9ad49f403247 33 fields · synced Jun 1, 2026