GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · JIAXING Zhejiang, CN · Registration 3004911384

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
3004911384
FEI Number
3004911384
Entity Name
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.
City/State/Country
JIAXING Zhejiang, CN
Establishment Address
1805 HONGGAO ROAD, Xiuzhou Industry Zone, JIAXING Zhejiang 314031, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Alleset, Inc. (Owner Number: 10040018)
Owner / Operator Contact Address
4142 INDUSTRy Way, Flowery Branch, GA 30542, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Invenio Access Safety Kit (ASK) Merit Custom Kit Angiographic Procedure Packs Equipment Covers Invenio Drape, patient, opthalmic Alleset Alleset Halyard Invenio Invenio gentleheel® Adult Incision Device piston Syringe Medline Microtek GRI-Alleset Alleset Tip Cleaner PenBlade Safety Scalpel Bard-Parker Invenio Alleset Alleset Alleset Invenio Electrosurgical pencil Invenio Alleset Syringe, Irrigating (non dental) Alleset Alleset Invenio Invenio Alleset Microtek Equipment Covers Invenio Surgical Drape Alleset Surgical Drape Alleset Equipment Covers OcuDrape Equipment Covers Invenio Equipment Covers Beaver-Visitec International. Inc Surgical Drape Beaver-Visitec International. Inc Fluid Collection Bag Beaver-Visitec International. Inc Equipment Covers Invenio Invenio Halyard Alleset CUSTOM ASSEMBLIES Tubing, Noninvasive- CMS Invenio GRI-Alleset Alleset Invenio Alleset Alleset Invenio ECOLAB Alleset Surgical Gown Alleset Invenio RoyalGuard Surgical Gown, I600, Breathable Covidien Alleset Invenio

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OFC Catheter Introducer Kit Cardiovascular Class 2 870.1340 2021-09-23
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2023-03-01
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-12-08
PAD Chest Drainage Kit General Hospital Class 2 880.6740 2021-09-23
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2022-01-27
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2026-03-04
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2021-09-22
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2014-10-28
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2021-09-23
OFG Ct Biopsy Tray Cardiovascular Class 2 870.4075 2021-09-23
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-03-03
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-01-24
PXI Thoracentesis Tray General Hospital Class 2 880.5570 2024-09-12
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-11-27
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2021-09-23
HXD Clamp General, Plastic Surgery Class 1 878.4800 2021-09-22
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-07-08
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2021-09-23
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2021-09-23
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2021-09-23
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2021-09-23
POZ Biopsy Needle Kit Gastroenterology, Urology Class 2 876.1075 2024-09-12
OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat Class 1 874.4420 2020-09-15
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2021-09-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-01-24
OFL Percutaneous Sheath Introducer Kit Cardiovascular Class 2 870.1340 2023-05-06
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2021-09-23
OEQ Angiography/Angioplasty Kit Cardiovascular Class 2 870.1650 2021-09-23
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2022-07-26
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2021-09-22
PPA Bladder Irrigation Kit Gastroenterology, Urology Class 2 876.5130 2021-09-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-09-23
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2023-05-24
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2021-09-23
PPQ Transtibial Anterior Cruciate Ligament Kit Orthopedic Class 2 888.3040 2021-09-23
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2021-09-23
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2024-05-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-09-22
FTN Plastic Surgery And Accessories Kit General, Plastic Surgery Class 1 878.3925 2021-09-23
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2021-09-23
FNY Basin, Emesis General Hospital Class 1 880.6730 2021-09-22
PZG Surgical Eye Tray Ophthalmic Class 1 886.4350 2026-02-25
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2021-09-22
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2021-09-22
OJG Neurological Tray Neurology Class 1 882.4525 2021-09-23
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2021-09-22
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2021-09-22
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2021-09-21
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2021-09-23
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2021-09-23
OHM Cesarean Section Tray Obstetrics/Gynecology Class 2 884.1720 2020-09-15
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-08-10
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2021-09-22
OES Cardiac Catheterization Kit Cardiovascular Class 2 870.1200 2021-09-23

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Paugh Email: mpaugh@gri-china.com Phone: (678) 5238977

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009203853 GRI-Alleset, Inc. Flowery Branch, GA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23
K192019 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 2019-11-08
K230411 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter 2023-04-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2007 GE OEC Medical Systems, Inc 2
GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009 Philips Medical Systems North America Co. Phillips 2
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010 Ge Healthcare 2
GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010 Ge Healthcare 2
GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04 Siemens Medical Solutions USA, Inc 2
Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004911384. Last updated year: 2026. Please use registration number 3004911384 when referencing this establishment in official correspondence.
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