FDA Registration
Active
🇨🇳 China
YADU MEDICAL (HENAN) CO., LTD
Reg #: 3034629649
·
FEI: 3034629649
·
Expires 2026
Products
30
Proprietary Names
62
Establishment Types
5
Classifications
30
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Registration Details
- Registration Name
- YADU MEDICAL (HENAN) CO., LTD
- Registration Number
- 3034629649
- FEI Number
- 3034629649
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.66, Yangze Road, Nanpu District, 453400 Changyuan, Henan Province, PEOPLE'S REPUBLIC OF CHINA
- City
- Changyuan Henan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K252301
Owner / Operator
- Firm Name
- YADU Medical (Henan) Co., Ltd
- Operator Number
- 10092032
- Address
- No.66, Yangze Road, Nanpu District, 453400 Changyuan, Henan Province, PEOPLE'S REPUBLIC OF CHINA
- City
- Changyuan
- State
- Henan
- Postal Code
- 453400
- Country
- CN
- Correspondent
- Winnie Li
US Agent
- Business Name
- Humiss Inc.
- Contact Name
- James St. WU
- Address
- 1942 Broadway St., STE 314C, Boulder, Co,80302, USA Boulder, Colorado,80302, UNITED STATES
- City
- Boulder
- State
- CO
- ZIP
- 80302
- Country
- US
- [email protected]
- Phone
- 720 7595888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2025-09-26 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2024-11-26 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2026-05-25 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2024-11-28 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2024-11-28 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2025-01-08 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2024-12-02 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2024-12-02 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2024-11-28 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-11-28 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2024-12-12 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2025-02-23 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2024-12-05 |
| Pouch, Colostomy | EZQ | Class 1 | Gastroenterology, Urology | No | 2024-11-28 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2024-11-28 |
| Kit, First Aid, Talking | OVR | Class 1 | General, Plastic Surgery | No | 2024-12-02 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2024-11-28 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-12-12 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2026-05-06 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2024-12-02 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2024-12-02 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2024-12-12 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-01-08 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2024-12-02 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2025-01-08 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2024-11-28 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2025-07-17 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2024-11-28 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-05-27 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2024-11-28 |
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
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
Urine bag
Patient Gowns
Procedure Packs
Dressing Packs
Surgical Pack
Bed Sheet
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility