MeMed BV

Procalcitonin Assay

MeMed Diagnostics Ltd.

The following data is part of a premarket notification filed by Memed Diagnostics Ltd. with the FDA for Memed Bv.

Pre-market Notification Details

Device IDK210254
510k NumberK210254
Device Name:MeMed BV
ClassificationProcalcitonin Assay
Applicant MeMed Diagnostics Ltd. Nahum Heth 5 Tirat Carmel,  IL 3508504
ContactEfrat Hartog-david
CorrespondentEfrat Hartog-david
MeMed Diagnostics Ltd. Nahum Heth 5 Tirat Carmel,  IL 3508504
Product CodePRI  
CFR Regulation Number866.3215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-29
Decision Date2021-09-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290018739034 K210254 000
17290018739027 K210254 000
17290018739003 K210254 000
17290018739010 K210254 000

Trademark Results [MeMed BV]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEMED BV
MEMED BV
79286202 not registered Live/Pending
MeMed Diagnostics Ltd.
2020-04-21

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