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 ID | K210254 |
| 510k Number | K210254 |
| Device Name: | MeMed BV |
| Classification | Procalcitonin Assay |
| Applicant | MeMed Diagnostics Ltd. Nahum Heth 5 Tirat Carmel, IL 3508504 |
| Contact | Efrat Hartog-david |
| Correspondent | Efrat Hartog-david MeMed Diagnostics Ltd. Nahum Heth 5 Tirat Carmel, IL 3508504 |
| Product Code | PRI |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-29 |
| Decision Date | 2021-09-01 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 79286202 not registered Live/Pending |
MeMed Diagnostics Ltd. 2020-04-21 |
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