Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015142721

FEI Number

3015142721

Entity Name

ZHEJIANG HUANYI STERILIZATION TECHNOLOGY CO., LTD

City/State/Country

huzhou Zhejiang, CN

Establishment Address

No. 199, Mingzhu avenue, leidian development zone, deqing county, huzhou Zhejiang 313219, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Zhejiang Huanyi Sterilization Technology Co., Ltd (Owner Number: 10059245)

Owner / Operator Contact Address

No. 199, Mingzhu avenue, leidian development zone, deqing county, huzhou, CN-ZJ 313219, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Assure ID Safety Pen Needle Plaster gauze bandage Verifine Safety Syringe with Fixed Needle BroncTru Transbronchial Access Tool BioStar® Transbronchial Aspiration Needle Suction Catheter Kit VeriSafe Safety sterile syringes Insulin syringe Promisemed X-Safety Pen Needle Labeling Information - Pilot Program Participants Only Blood collection holder Verisafe Safety sterile needles Verifine blunt needle Catheterization Kit ClearVision Single Use Hysteroscope & Image Processing System Enfit oral syringe

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	2019-09-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-12-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-03-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-12-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2018-12-25
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2021-03-11
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-06-08
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-04-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-04-26
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-07-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-01-10
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2021-03-11
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-07-14
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2021-03-11
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2018-12-25
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-08-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-11-02
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2023-11-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-06-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-09-27
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-11-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-03-11
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2022-04-26
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2018-12-14
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2023-06-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-11-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-06-27
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2024-11-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-06-09
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-11-02
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2018-12-25
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-12-28
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2021-03-11
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2023-11-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-12-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-21

Official Correspondent

Dongxia Shen

US Agent Details

ZHENG XU Email: cathygeng2007@gmail.com Phone: (248) 5508758

Related Public Records

Same Entity

Zhejiang Huanyi Sterilization Technology Co., Ltd

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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

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
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015142721. Last updated year: 2026. Please use registration number 3015142721 when referencing this establishment in official correspondence.