ABA Medical Technology Co Ltd

FDA Device Registration & Listing · Guang dong Guangdong, CN · Registration 3007648309

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
3007648309
FEI Number
3007648309
Entity Name
ABA Medical Technology Co Ltd
City/State/Country
Guang dong Guangdong, CN
Establishment Address
No. 32, Qio Long Village, Sha Bu Industrial Park, TanqXia, DongGuan, Guang dong Guangdong 523730, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
AMC (Owner Number: 10029288)
Owner / Operator Contact Address
11705 NW 39th Street, Coral Springs, FL 33065, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AMC Cables ABI Bipolar Cable/Cord Bipolar Single Use Cable ABI Monopolar Cable/Cord ABI Bipolar Cable/Cord Electrophysiology Cable

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2021-10-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-04-27
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2023-06-27
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2023-06-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-01-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-04-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-04-27
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2026-01-29

Official Correspondent

Renee Pierre

US Agent Details

Renee Pierre Business: Lifesync Corp Email: iwest@lifesync.com Phone: (954) 3459800

Related Public Records

Same Entity

AMC
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
K880323 Medtronic Vascular MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR 1988-03-22
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-1670-2013 Abbott Medical Optics, Inc. 2
Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024 Alcon Research, LLC 2
Constellation Vision System, REF: 8065751150
Z-0305-2026 Alcon Research LLC 2
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020 Alcon Research LLC 2
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007648309. Last updated year: 2026. Please use registration number 3007648309 when referencing this establishment in official correspondence.
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