YO Home Sperm Test YO-FA-01469-00

GUDID 07290016650273

M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Motile sperm concentration IVD, kit, imaging, self-testing
Primary Device ID07290016650273
NIH Device Record Keye641a783-e8a1-4d99-816a-56568c2c6860
Commercial Distribution StatusIn Commercial Distribution
Brand NameYO Home Sperm Test
Version Model NumberFor YO Universal 1.0
Catalog NumberYO-FA-01469-00
Company DUNS514680529
Company NameM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016650273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

POVSemen Analysis Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-11

On-Brand Devices [YO Home Sperm Test]

07290016650273For YO Universal 1.0
07290016650266For iPhone 8 Plus
07290016650259For iPhone 8
07290016650242For Galaxy J7
07290016650235For iPhone X
07290016650228For iPhone 7 Plus
07290016650211For Galaxy J2
07290016650204For Xiaomi mi 5
07290016650198For Galaxy S8 plus
07290016650181For Galaxy S8
07290016650174For Huawei Honor 6
07290016650167For Huawei Mate 9
07290016650150For Xiaomi Note 4
07290016650143For LG G6
07290016650136For LG G5
07290016650112For Iphone 6 plus/ 6s plus/ 7 plus
07290016650105For Galaxy 7 Edge
07290016650082For Galaxy 7
07290016650075For Galaxy 6
07290016650068For I-Phone 7
07290016650051For I-Phone 6
07290012140983For I-Phone 5/5S/SE
07290016650365YO: Universal 2.0 packed kit - 6 tests
07290016650358YO: Universal 2.0 packed kit - 4 tests
07290016650341YO: Universal 2.0 packed kit - 2 tests

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