Yadu Medical (Henan) Co., Ltd.
Manufacturer and brand owner in Changyuan, Henan, China. 30 device types, 1 product catalogued, 3 clearances.
Yadu Medical (Henan) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Gown, Surgical and 28 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
30device types registered with the FDA
1product
3510(k) clearances
Registration
| Registered name | YADU MEDICAL (HENAN) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3034629649 |
| FEI number | 3034629649 |
| DUNS | 542078504 |
| Establishment type | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 亚都医疗科技（河南）有限公司 |
|---|---|
| Unified social credit code | 91410728MA3X7TCN43 |
| Source | NMPA UDI database |
Location
| City | Changyuan |
|---|---|
| Province | Henan |
| Address | No.66, Yangze Road, Nanpu District, 453400 Changyuan, Henan Province, PEOPLE’S REPUBLIC OF CHINA |
| 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 | 2024 | 46 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Urine bag | 2025 | 52 |
| Bandage, Liquid, Skin Protectant | Class 1 | Sensi-Care Skin Barrier Sprays, Trio Silesse, Esenta Skin barrier Sprays, Wipes, Foam applicators | 2024 | 41 |
| Bedding, Disposable, Medical | Class 1 | Bed Sheet | 2024 | 308 |
| Brush, Scrub, Operating-Room | Class 1 | Patient Gowns | 2024 | 42 |
| Cannula, Nasal, Oxygen | Class 1 | Oxygen Cannula | 2024 | 97 |
| Cap, Surgical | Class 1 | Caps | 2024 | 178 |
| Catheter And Tip, Suction | Class 2 | Surgical Suction Instrume, Suction Tubing with Yankauer Handle, Suction Tubing, Connecting Tube, Surgical Aspirator Tip | 2024 | 70 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suction Catheter Kit, Suction Catheter | 2024 | 93 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Breathing circuits | 2024 | 55 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe Covers | 2024 | 176 |
| Drape, Surgical, Exempt | Class 2 | Mayo stand cover, Surgical Drape | 2024 | 107 |
| Garment, Protective, For Incontinence | Class 1 | Nursing pad, Protective garment for incontinence, Adult pad, Under pad, Adult diaper, Baby diaper and 1 more | 2024 | 181 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Absorbent Cotton Wool, Gauze Swabs, Cotton Wool Roll, HALF COMPRESSED Cotton Wool Roll, COMPRESSED Cotton Wool Roll, Dressing Gauze and 6 more | 2024 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Stretch Gauze Bandage | 2024 | 67 |
| Gown, Examination | Class 1 | coveralls | 2024 | 109 |
| Gown, Surgical | Class 2 | Surgical Gown Level2, NR/FR, YADU Surgical gown, Surgical Gown Level3, PR, Surgical Gown Level4 | 2025 | 68 |
| Kit, First Aid, Talking | Class 1 | First Aid Kit | 2024 | 18 |
| Kit, Surgical Instrument, Disposable | Class 1 | Surgical pack | 2026 | 67 |
| Mask, Scavenging | Class 1 | Face Masks | 2024 | 158 |
| Non-Surgical Gown | Class 1 | Scrub Suits, Lab jacket, Lab coat, Coveralls, Isolation Gowns | 2024 | 318 |
| Pack, Heat, Moist | Class 1 | Dressing Packs, Procedure Packs | 2024 | 39 |
| Pouch, Colostomy | Class 1 | Liquid Pouches | 2024 | 25 |
| Respirator, Surgical | Class 2 | Particulate Respirator FFP2 NR | 2025 | 118 |
| Speculum, Vaginal, Nonmetal | Class 2 | Disposable Vaginal Speculum | 2026 | 40 |
| Suit, Surgical | Class 1 | Isolation Gowns, Coveralls, Scrub Suits | 2024 | 74 |
| Tape And Bandage, Adhesive | Class 1 | Stretch Gauze Bandage | 2025 | 353 |
| Tray, Surgical, Instrument | Class 1 | Surgical Pack | 2026 | 105 |
| Tubing, Noninvasive | Class 2 | Suction Tubing | 2025 | 33 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Yadu | FYA | 18 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261028 | 2026-08-07 | FYA | Traditional | This company |
| K252301 | 2026-02-04 | FYA | Traditional | This company |
| K250564 | 2025-12-03 | FYA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Employees | 1800+ |
| Factory area | 400,000 m² |
| Main products | surgical gowns, drapes, surgical kits, sponges, gauzes, anesthesia products |
| Certifications | ISO 9001, ISO 13485, CE |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Henan Yadu Industrial Co., Ltd. | 35 |
| 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.