Henan Yadu Industrial Co., Ltd.
Registered establishment in Changyuan, Henan, China. 35 device types, 2 clearances.
Henan Yadu Industrial Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Cap, Surgical and 33 other device types. Its earliest product listing with the FDA dates from 2020.
35device types registered with the FDA
2510(k) clearances
Registration
| Registered name | HENAN YADU INDUSTRIAL CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016452400 |
| FEI number | 3016452400 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer |
Location
| City | Changyuan |
|---|---|
| Province | Henan |
| Address | No. 66 Yangze Road, Nanpu District |
| Postal code | 453400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | Class 1 | Applicator, Absorbent Tipped, Sterile | 2025 | 100 |
| Apron, Protective | Class 1 | Apron | 2022 | 46 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Urine bag | 2024 | 52 |
| Bandage, Liquid, Skin Protectant | Class 1 | Esenta Skin barrier sprays, Wipes, Trio Silesse, Foam applicators, Sensi-Care Skin Barrier Sprays | 2022 | 41 |
| Bedding, Disposable, Medical | Class 1 | Bed Sheet | 2020 | 308 |
| Brush, Scrub, Operating-Room | Class 1 | Patient Gowns | 2021 | 42 |
| Cannula, Nasal, Oxygen | Class 1 | Oxygen Cannula | 2022 | 97 |
| Cap, Surgical | Class 1 | Caps, Bouffant Style Surgery Cap | 2020 | 178 |
| Catheter And Tip, Suction | Class 2 | Yankauer Bulb, Suction Tubing, Connecting Tube, Surgical Aspirator Tip, Yankauer, Surgical Suction Set with Tubing and 3 more | 2024 | 70 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suction Catheter | 2020 | 93 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Breathing circuits | 2022 | 55 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe Covers, Non-Skid Shoe Cover | 2020 | 176 |
| Drape, Surgical, Exempt | Class 2 | Surgical Drape | 2021 | 107 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit | 2022 | 132 |
| Garment, Protective, For Incontinence | Class 1 | Adult diaper;Adult pad; Baby diaper; Baby pad;Nursing pad; Under pad;Protective garment for incontinence | 2023 | 181 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Cotton Swab Sticks, Gauze Swabs, COMPRESSED Cotton Wool Roll, HALF COMPRESSED Cotton Wool Roll, Cotton Wool Roll, Lap Sponges and 5 more | 2022 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Laparotomy sponge, Internal, X-Ray Detectable, X-Ray Detectable Gauze Sponges | 2024 | 67 |
| Gown, Examination | Class 1 | coveralls, Lab coat | 2020 | 109 |
| Gown, Surgical | Class 2 | NR/FR, PR, YADU Surgical Gowns | 2021 | 68 |
| Kit, First Aid, Talking | Class 1 | First Aid Kit | 2022 | 18 |
| Mask, Gas, Anesthetic | Class 1 | Anesthetic Masks, Aerosol Mask | 2020 | 71 |
| Mask, Oxygen | Class 1 | Oxygen Masks | 2020 | 126 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Non-Rebreathing Mask | 2022 | 72 |
| Mask, Scavenging | Class 1 | Face Masks | 2020 | 158 |
| Mask, Surgical | Class 2 | YADU Surgical Masks, Cypress | 2020 | 125 |
| Non-Surgical Gown | Class 1 | Coveralls, Isolation Gowns, Lab coat, Lab jacket | 2020 | 318 |
| Pack, Heat, Moist | Class 1 | Dressing Packs, Procedure Packs | 2020 | 39 |
| Pouch, Colostomy | Class 1 | Liquid Pouches | 2020 | 25 |
| Protector, Ostomy | Class 1 | Protective Barrier Wipe | 2023 | 33 |
| Respirator, Surgical | Class 2 | Particulate Respirator FFP2 NR | 2024 | 118 |
| Solvent, Adhesive Tape | Class 1 | Adhesive Remover Wipe | 2023 | 20 |
| Suction Catheter Kit | Class 1 | Suction Catheter Kit | 2022 | 1 |
| Suit, Surgical | Class 1 | Scrub Suits | 2022 | 74 |
| Tape And Bandage, Adhesive | Class 1 | Stretch Gauze Bandage | 2024 | 353 |
| Tracheostomy And Nasal Suctioning Kit | Class 1 | Tracheostomy Mask | 2022 | 6 |
Clearances
2 clearances name Henan Yadu Industrial Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220092 | 2022-10-07 | FYA | Traditional | This company |
| K212330 | 2022-03-14 | FXX | Traditional | This company |
| K972883 | 1998-02-26 | FXX | Traditional | Cypress Medical Products, Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Yadu Medical (Henan) Co., Ltd. | 30 |
| Evereast Medical Products Group Co., Ltd. | 30 |
| Henan Maidingkang Medical Technology Co., Ltd. | 7 |
| Henan Robestain Medical Products Co., Ltd. | 5 |
| Henan Tuoren Medical Device Co., Ltd. | 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.