MEDENOVATE

FDA Device Registration & Listing · Irvine, CA, US · Registration 3032953138

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032953138
FEI Number
3032953138
Entity Name
MEDENOVATE
City/State/Country
Irvine, CA, US
Establishment Address
25 Mauchly Ste 326, Irvine, CA 92618, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Medenovate (Owner Number: 10091456)
Owner / Operator Contact Address
25 Mauchly, 326, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PeriNi

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2024-10-05

Official Correspondent

Jerome Choe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medenovate
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032953138. Last updated year: 2026. Please use registration number 3032953138 when referencing this establishment in official correspondence.
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