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SQA-Vision Sperm Quality Analyzer

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
SQA-Vision Sperm Quality Analyzer FDA UDI
Generic Name
Spermatozoa/semen analyser IVD FDA UDI
Model / Reference
VS-MA-00892-00 FDA UDI

Identifiers

Catalog Number
VS-MA-00892-00 FDA UDI
Primary DI / UDI-DI
07290012140792 FDA UDI
510(k) Number
K012352 FDA UDI
FDA Product Code
GKZ 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

No

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-Vision 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.

Cleared under the same submission

K012352 also covers:

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 3ba2142d-dd48-4f37-9286-f4cb3298978a 34 fields · synced May 30, 2026