Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680222

FEI Number

3003154916

Entity Name

ZHEJIANG MEDICINES & HEALTH PRODUCTS I/ E CO., LTD.

City/State/Country

HANGZHOU, ZHEJIANG, CN

Establishment Address

6-7F,310 NORTH ZHONGSHAN RD., HANGZHOU, ZHEJIANG 310003, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ZHEJIANG MEDICINES & HEALTH PRODUCTS IMPORT & EXPO (Owner Number: 9007317)

Owner / Operator Contact Address

101-2 NORTH ZHONGSHAN RD., ZMC BLDG., HANGZHOU, ZHEJIANG, CN-NOTA 310003, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Needle Gauge: 30G, 29G, 28G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, 20G, 19G, 18G Disposable Syringes with/without Needle,Syringe volume: 1ml, 2ml, 2.5ml, 3ml, 5m,10ml, 20ml, 30ml, 50ml, 60ml STERILIZATION POUCHES ALL SIZES CREPE PAPER all sizes STERILIZATION PAPER all sizes CERVICAL SPATULA, STERILE/NON STERILE CERVICAL AYRE SPATULA COTTON ROLLS COTTON BALLS COTTON WOOL NON-REBREATHING MASK Syringe Sterile hypodemic needle for single use Inslin syringe BLOOD COLLECTION TUBES all types and all sizes VACUUM SYSTEM X-RAY DETECTABLE GAUZE SPONGE USP TYPE V ALL MESHES AND ALL SIZES LAP SPONGE USP TYPE V ALL MESHES AND ALL SIZES Administration set Infusion set with burette 100ml, 150ml IV SET, with/without needle, tube length 1.2m-2m Quincke Spinal Needle all sizes Spinal needle all sizes Surgical Drapes Clip Cap Non woven Cap Surgical Cap Disposable Cap Cast padding bandage all sizes NEBULIZER MASKS, ALL SIZES Elastic bandage all sizes Crepe bandage Gauze roll Gauze piece USP Type V in all meshes and all sizes Gauze bandage USP Type V in all meshes and all sizes Gauze sponge WOODEN TONGUE DEPRESSORS, NON-STERILE, SPATULA COLOSTOMY BAGS OSTOMY BAGS Insulin syringe 1ml or 0.5ml with needle 29G*5mm; 29G*8mm; 29G*10mm; 29G*12.5mm; 30G*5mm; 30G*8mm; 30G*10mm; 30G*12.5mm; MEDICAL MASK SURGICAL MASK FACE MASK STERILIZATION PAPER all sizes DENTAL APRON, BIBS CREPE PAPER all sizes IRRIGATING SYRINGE, BULB SYRINGE, 50ML, 60ML, 100ML Scalpel Surgical Blade all sizes Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) 45-50g SMMS Surgical gown 40gsm SMS Surgical gown standard SMS surgical gown reinforced Absorbent Cotton Wool Cotton Balls Cotton Roll COTTON TIPPED APPLICATOR Blemish patch Adhesive Island Dressing NASAL CANNULA BINASAL CANNULA

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	2025-06-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-06-27
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2025-07-03
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2025-07-03
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2010-09-01
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2014-10-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-04-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-04-27
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2025-06-13
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2000-09-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-05-12
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2021-04-27
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2018-07-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2007-04-10
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-04-10
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2019-07-12
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2011-10-14
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2019-07-12
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2018-07-05
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2011-10-14
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-07-12
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2013-01-29
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2011-04-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-06-27
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2020-08-06
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-03-20
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2012-03-20
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2025-06-13
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-06-13
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-03-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-04-28
EFN	Cotton, Roll	Dental	Class 1	872.6050	2021-04-27
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2019-07-14
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2011-05-25
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2019-07-12

Official Correspondent

No official correspondent registered.

US Agent Details

Aliaksandra Ayukava Business: American International Health and Beauty Association Inc. Email: compliance@aihba.com Phone: (888) 4073022

Related Public Records

Same Entity

ZHEJIANG MEDICINES & HEALTH PRODUCTS IMPORT & EXPO

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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03

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 9680222. Last updated year: 2026. Please use registration number 9680222 when referencing this establishment in official correspondence.