Data / Medical devices / China / Gri Medical & Electronic Technology Co., Ltd.
Gri Medical & Electronic Technology Co., Ltd.: FDA-registered device maker in JIAXING Zhejiang, China, 10 510(k) clearances
Gri Medical & Electronic Technology Co., Ltd. is registered with the FDA (registration 3004911384) in JIAXING Zhejiang, China. It lists 74 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 5, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004911384
- Address
- 1805 HONGGAO ROAD Xiuzhou Industry Zone, JIAXING Zhejiang, China, 314031
- Owner or operator
- Alleset, Inc. (10040018)
- Roles
- Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 28, 2014
- Registered through
- 2027
- Brand names listed
- 3M, Access Safety Kit (ASK), Alleset, Alleset Equipment Covers, Alleset Inc.,, Alleset Surgical Drape, Angiographic Procedure Packs, Bard-Parker and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Anesthesia Kit | OFQ | 2 | Manufacturer | accessdata.fda.gov |
| Angiography/Angioplasty Kit | OEQ | 2 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Manufacturer | accessdata.fda.gov |
| Battery-Powered Instruments Charged Through Sterile Barriers | SAM | 1 | Contract manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Biopsy Needle Kit | POZ | 2 | Manufacturer | accessdata.fda.gov |
| Bladder Irrigation Kit | PPA | 2 | Manufacturer | accessdata.fda.gov |
| Cardiac Catheterization Kit | OES | 2 | Manufacturer | accessdata.fda.gov |
| Cardiovascular Procedure Kit | OEZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Manufacturer | accessdata.fda.gov |
| Catheter Introducer Kit | OFC | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Exporter to the US | accessdata.fda.gov |
| Cesarean Section Tray | OHM | 2 | Manufacturer | accessdata.fda.gov |
| Chest Drainage Kit | PAD | 2 | Manufacturer | accessdata.fda.gov |
| Clamp | HXD | 1 | Manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Manufacturer | accessdata.fda.gov |
| Ct Biopsy Tray | OFG | 2 | Manufacturer | accessdata.fda.gov |
| D And C Tray | PKF | N | Manufacturer | accessdata.fda.gov |
| D&C Tray | PVR | 2 | Manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Patient, Ophthalmic | HMT | 2 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Ear, Nose, And Throat Surgical Tray | OGR | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Exporter to the US | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Gynecological Laparoscopic Kit | OHD | 2 | Manufacturer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Labor And Delivery Kit | MLS | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscopy Kit | FDE | 2 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Manufacturer | accessdata.fda.gov |
| Myringotomy Procedure Kit | OGS | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Manufacturer | accessdata.fda.gov |
| Neurological Tray | OJG | 1 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Tray | OJH | 1 | Manufacturer | accessdata.fda.gov |
| Percutaneous Sheath Introducer Kit | OFL | 2 | Exporter to the US | accessdata.fda.gov |
| Plastic Surgery And Accessories Kit | FTN | 1 | Manufacturer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Contract manufacturer, Contract sterilizer, Exporter to the US | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Contract manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Manufacturer | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Manufacturer | accessdata.fda.gov |
| Surgical Eye Tray | PZG | 1 | Manufacturer | accessdata.fda.gov |
| Suture Removal Kit | MCZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Contract manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Thoracentesis Tray | PXI | 2 | Manufacturer | accessdata.fda.gov |
| Transtibial Anterior Cruciate Ligament Kit | PPQ | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Manufacturer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Manufacturer | accessdata.fda.gov |
| Urinary Irrigation Kit | PPF | 2 | Manufacturer | accessdata.fda.gov |
| Venipuncture Kit | PXL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| November 5, 2024 | K242664 | gentleheel® Adult Incision Device | FMK | Substantially Equivalent | Gri-Alleset, Inc. | accessdata.fda.gov |
| May 18, 2022 | K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | FMK | Substantially Equivalent | Gri-Alleset, Inc. | accessdata.fda.gov |
| December 8, 2017 | K172445 | RoyalGuard Surgical Gown, i600, Breathable | FYA | Substantially Equivalent | Gri Medical & Electrical Technology Co., Ltd. | accessdata.fda.gov |
| December 12, 2016 | K162442 | ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 | FYA | Substantially Equivalent | Gri Medical & Electrical Technology Co., Ltd. | accessdata.fda.gov |
| August 11, 2011 | K111282 | DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES | FLL | Substantially Equivalent | Starboard Medical, LLC | accessdata.fda.gov |
| July 29, 2011 | K103830 | JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) | FMF | Substantially Equivalent | Jiangsu Shenli Medical Production Factory | accessdata.fda.gov |
| February 3, 2011 | K102652 | NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS | FYA | Substantially Equivalent | Gri Medical & Electronic Technology Co., Ltd. | accessdata.fda.gov |
| December 1, 2009 | K092634 | OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF | GEI | Substantially Equivalent | Jiangmen City Xinhui Baisheng Medical Equipment CO | accessdata.fda.gov |
| November 15, 1991 | K913682 | MERIT CUSTOM KIT | DQO | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| April 12, 1985 | K851090 | MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|
| August 26, 2026 | 99813 | Class II | Ongoing | HALYARD Laparoscopy Comprehensive Pack II REF: 49332 | Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter | accessdata.fda.gov |
Compare with other makers
Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.