PROSUM MEDICAL LIMITED

FDA Device Registration & Listing · London London, City of, GB · Registration 3029905131

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
3029905131
FEI Number
3029905131
Entity Name
PROSUM MEDICAL LIMITED
City/State/Country
London London, City of, GB
Establishment Address
Unit 14 Cowley Mill Road, Uxbridge, London London, City of UB8 2DB, GB
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Prosum Medical Limited (Owner Number: 10088954)
Owner / Operator Contact Address
Unit 14 Cowley Mill Road, Uxbridge, GB-LND UB8 2DB, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233037
PMA Number
N/A

All Registered Proprietary Names

Bubble Adaptor, Sterile, Single - use Blunt Fill Needle (without / with filter) Needle Hypodermic Needle Disposable Needle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2023-11-08
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2023-11-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-10-31

Official Correspondent

Yanshen Sun

US Agent Details

Joe Xia Business: LSI International Inc Email: jxia@lsi-consulting.org Phone: (240) 5057880

Related Public Records

Same Entity

Prosum Medical Limited
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
K781371 Ferris Mfg. Corp. BONE MARROW ASPIRATION KIT 1978-09-20
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011 Becton Dickinson & Company 1
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
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 3029905131. Last updated year: 2026. Please use registration number 3029905131 when referencing this establishment in official correspondence.
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