YADU MEDICAL (HENAN) CO., LTD

FDA Device Registration & Listing · Changyuan Henan, CN · Registration 3034629649

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
3034629649
FEI Number
3034629649
Entity Name
YADU MEDICAL (HENAN) CO., LTD
City/State/Country
Changyuan Henan, CN
Establishment Address
No.66, Yangze Road, Nanpu District, 453400 Changyuan, Henan Province, PEOPLE'S REPUBLIC OF CHINA, Changyuan Henan 453400, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
YADU Medical (Henan) Co., Ltd (Owner Number: 10092032)
Owner / Operator Contact Address
No.66, Yangze Road, Nanpu District, 453400 Changyuan, Henan Province, PEOPLE'S REPUBLIC OF CHINA, Changyuan, CN-HA 453400, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

YADU Surgical gown Isolation Gowns Lab coat Lab jacket Coveralls Scrub Suits Disposable Vaginal Speculum CAPS Shoe Covers Particulate Respirator FFP2 NR NR/FR Apron Oxygen Cannula Face Masks Surgical Drape Mayo stand cover coveralls PR Applicator, Absorbent Tipped, Sterile Surgical Aspirator Tip Suction Tubing Connecting Tube Suction Tubing with Yankauer Handle Surgical Suction Instrume Liquid Pouches Scrub Suits Isolation Gowns Coveralls First Aid Kit Suction Catheter Kit Suction Catheter Non-woven Sponge HALF COMPRESSED Cotton Wool Roll Cotton ball Cotton Wool Roll Absorbent Cotton Wool Cotton Swab Sticks COMPRESSED Cotton Wool Roll Dressing Gauze Lap Sponges Gauze Swabs Cotton Wool Pleats Surgical pack Surgical Gown Level4 Baby pad Under pad Protective garment for incontinence Baby diaper Nursing pad Adult diaper Adult pad Breathing circuits Foam applicators Trio Silesse Sensi-Care Skin Barrier Sprays Esenta Skin barrier Sprays Wipes Surgical Gown Level3 Stretch Gauze Bandage

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2025-09-26
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2024-11-26
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2026-05-25
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2024-11-28
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2024-11-28
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2025-01-08
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2025-06-17
IWO Apron, Protective Radiology Class 1 892.6500 2024-12-02
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2024-12-02
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2024-11-28
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2024-11-28
FME Gown, Examination General Hospital Class 1 880.6265 2024-12-12
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2025-06-17
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2025-02-23
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2024-12-05
EZQ Pouch, Colostomy Gastroenterology, Urology Class 1 876.5900 2024-11-28
FXO Suit, Surgical General, Plastic Surgery Class 1 878.4040 2024-11-28
OVR Kit, First Aid, Talking General, Plastic Surgery Class 1 878.4014 2024-12-02
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2024-11-28
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2024-12-12
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2026-05-06
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2026-02-11
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2024-12-02
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2024-12-02
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2024-12-12
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2025-12-16
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2025-01-08

Official Correspondent

Winnie Li

US Agent Details

James St. WU Business: Humiss Inc. Email: cc401vip@126.com Phone: (720) 7595888

Related Public Records

Same Entity

YADU Medical (Henan) 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
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K102092 Prestige Ameritech PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES 2010-10-06
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2013 Invuity, Inc. 2
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0033-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04 VIASYS Med Systems 1
Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04 VIASYS Med Systems 1
Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

Similar Registrations

Registration Number Establishment Name Location
3042245424 Sino Protection Holding Co Limited Egypt Branch Ismailia Free Zone Ismailia Al Isma'iliyah, EG
3016678045 Schneider ASR B.V. Rotterdam-Albrandswaard Zuid-Holland, NL
8030672 Cirpro de Delicias S. de R.L. de C.V. DELICIAS Chihuahua, MX
1527607 SRI Healthcare, LLC MASON, OH, US
3027977504 MEDLINE CHILE SPA Pudahuel Region Metropolitana, CL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034629649. Last updated year: 2026. Please use registration number 3034629649 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.