Hangzhou Primecare Medical Co.,Ltd.

FDA Device Registration & Listing · hangzhou Zhejiang, CN · Registration 3014637079

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
3014637079
FEI Number
3014637079
Entity Name
Hangzhou Primecare Medical Co.,Ltd.
City/State/Country
hangzhou Zhejiang, CN
Establishment Address
Room 408-409, Zancheng Center West, Shangcheng District, 310008 Hangzhou, PEOPLE'S REPUBLIC OF CHINA, hangzhou Zhejiang 310008, CN
Establishment Type(s)
Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Hangzhou Primecare Medical Co.Ltd (Owner Number: 10058286)
Owner / Operator Contact Address
Room 408-409, Zancheng Center west, Shangcheng District, 310008 Hangzhou, PEOPLE'S REPUBLIC OF CHINA, hangzhou, CN-ZJ 310008, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202698
PMA Number
N/A

All Registered Proprietary Names

Suction connecting tube; Extension tube Urethral Catheterization Tray (w/ or w/o Catheter) Speicmen Collector Urine/Stool, Non-Str; Specimen Container APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED Enteral feeding pump sets razor prep disposable, razor twin blade Enteral feeding sets Lub Jelly Syringe Enteral Specific transition connector Medication Bottle Adaptor Disposable Vaginal Speculum Extension Set Urine collector pediatric NS Trachestomy care kit Leg Bag, Drainage Bag, Urinary Drainage Bag Irrigation tray, irrigation syringe, Ear Ulcer syringe Laceration Tray IV START KIT Central Line Trays skin scrub Tray Dressing change kit Shave Prep Kit Convenience Kits instrument pack Urine collector pediatric st Skin Staple removal Kit; Suture removal kit /tray Latex Foley catheters, Silicone Foley catheters Suction catheter kit Pre-filled syringe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2018-08-29
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2020-03-24
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2018-08-29
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2018-08-29
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2025-03-19
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2025-01-07
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2018-08-29
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2018-08-29
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2020-12-18
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2021-12-29
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2025-01-07
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2024-08-01
NOA Device, Paste-On For Incontinence, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2018-08-29
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2018-08-29
LRQ Tracheostomy And Nasal Suctioning Kit Unknown Class 1 N/A 2019-04-26
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2018-08-15
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2018-08-29
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2018-08-29
EXI Device, Paste-On For Incontinence, Sterile Gastroenterology, Urology Class 1 876.5250 2018-08-29
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2019-05-05
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2019-01-29
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2019-04-27
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2020-12-16

Official Correspondent

Juan Wu

US Agent Details

Wei ZHANG Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Hangzhou Primecare Medical 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
K883982 Iberhospitex, S.A. DRENOVAC 1989-02-23
K060316 Fresenius Kabi Deutschland GmbH COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS 2006-06-23
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-04 Vital Concepts, Inc. 1
Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04 Vital Concepts, Inc. 1
Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04 Vital Concepts, Inc. 1
HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04 Vital Concepts, Inc. 1
HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04 Vital Concepts, Inc. 1
Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

Registration Number Establishment Name Location
3030413693 Medway Supplies Inc Lake Elsinore, CA, US
1062154 NDH MEDICAL, INC. Saint Petersburg, FL, US
3010594263 JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. Shuyang Jiangsu, CN
3015967359 Stryker Instruments Portage, MI, US
3003902679 ENTER MEDICAL CORPORATION Chiayi County, TW
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014637079. Last updated year: 2026. Please use registration number 3014637079 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.