MEDIBIO USA LLC

FDA Device Registration & Listing · Davie, FL, US · Registration 3014393881

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
3014393881
FEI Number
3014393881
Entity Name
MEDIBIO USA LLC
City/State/Country
Davie, FL, US
Establishment Address
12528 south Stonebrook Circle, Davie, FL 33330, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Medibio USA LLC (Owner Number: 10057070)
Owner / Operator Contact Address
12528 south Stonebrook Circle, Davie, FL 33330, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K171144
PMA Number
N/A

All Registered Proprietary Names

Medifine Carefine Ultra Medifine Ultra TRUEplus 3 bevel Sterile pen needles Carefine TRUEplus 5 bevel Sterile pen needles

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-02-16

Official Correspondent

Jatin Rajani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014393881. Last updated year: 2026. Please use registration number 3014393881 when referencing this establishment in official correspondence.
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