FDA Registration
Active
🇨🇳 China
ZHEJIANG MEDICINES & HEALTH PRODUCTS I/ E CO., LTD.
Reg #: 9680222
·
FEI: 3003154916
·
Expires 2026
Products
41
Proprietary Names
86
Establishment Types
1
Classifications
41
Registration Details
- Registration Name
- ZHEJIANG MEDICINES & HEALTH PRODUCTS I/ E CO., LTD.
- Registration Number
- 9680222
- FEI Number
- 3003154916
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6-7F,310 NORTH ZHONGSHAN RD.
- City
- HANGZHOU, ZHEJIANG
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222124
Owner / Operator
- Firm Name
- ZHEJIANG MEDICINES & HEALTH PRODUCTS IMPORT & EXPO
- Operator Number
- 9007317
- Address
- 101-2 NORTH ZHONGSHAN RD., ZMC BLDG.
- City
- HANGZHOU, ZHEJIANG
- State
- CN-NOTA
- Postal Code
- 310003
- Country
- CN
US Agent
- Business Name
- American International Health and Beauty Association Inc.
- Contact Name
- Aliaksandra Ayukava
- Address
- 519 8th Ave Fl 5
- City
- New York
- State
- NY
- ZIP
- 10018
- Country
- US
- [email protected]
- Phone
- 888 4073022
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-06-27 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-06-27 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2025-07-03 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2025-07-03 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2010-09-01 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2014-10-31 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2025-06-13 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2000-09-28 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2021-05-12 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2021-04-27 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2018-07-05 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2007-04-10 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2007-04-10 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2019-07-12 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2011-10-14 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2019-07-12 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2018-07-05 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2011-10-14 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2019-07-12 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2013-01-29 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2011-04-08 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2020-08-06 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-03-20 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2012-03-20 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2025-06-13 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2025-06-13 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2025-03-20 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2021-04-27 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2019-07-14 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2011-05-25 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2019-07-12 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2025-06-13 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2019-07-12 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2009-11-13 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2002-03-06 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2014-11-20 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2025-03-24 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2019-07-12 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 2021-04-30 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 1999-01-13 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-06-13 |
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
DENTAL APRON, BIBS
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
ENDOTRACHEAL TUBE with cuff and uncuffed all sizes
TRACHEAL TUBE all sizes
PAIN RELIEF PATCH
STEAM EYE MASK
Hot or Cold Disposable Pack
WARM PATCH
NON-SKID SHOE COVERS
ADHESIVE PATCH
PE Tape all sizes
Silk Tape all sizes
FOOT MASK
Micropore Tape
SLIMMING PATCH
Surgical tape
Health Patch
Adhesive bandage
MOUTH TAPE
Micropore Tape all sizes
FOOT PATCH
URINE COLLECTOR FOR BABY, 100ML, 200ML
URINE BAG FOR ADULT 2000ML, W/WO VALVE
OXYGEN MASK, ALL SIZES
Cast padding all sizes
Plaster of paris bandage all sizes
Vaginal speclum, all types and all sizes
MULTIPLE NEEDLES 21G, 22G, 23G
BLOOD COLLECTION NEEDLES
Establishment Types
Export Device to the United States But Perform No Other Operation on Device