Dongguan Shin YI Healthcare Products Factory
Manufacturer and brand owner in Dong Guan, Guangdong, China. 30 device types, 1 product catalogued, 2 clearances.
Dongguan Shin YI Healthcare Products Factory is a contract manufacturer holding a current FDA establishment registration. The registration covers Cover, Cast, Bandage, Cast and 28 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 1995.
Registration
| Registered name | DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9680357 |
| FEI number | 3004829691 |
| DUNS | 420101982 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 东莞欣意医疗保健制品厂 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dong Guan |
|---|---|
| Province | Guangdong |
| Address | No. 17, Banhu Rd, /No.54 Hong Sheng Road, Diao Lang Village |
| Postal code | 523750 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | surgical apparel Accessory | 2020 | 439 |
| Bandage, Cast | Class 1 | Bandage, cast | 2015 | 81 |
| Bedding, Disposable, Medical | Class 1 | bedding | 2008 | 308 |
| Cap, Surgical | Class 1 | Disposable Bouffant Caps | 1995 | 178 |
| Cover, Barrier, Protective | Class 2 | Equipment Cover / Band Bag | 2010 | 15 |
| Cover, Cast | Class 1 | cover | 2008 | 31 |
| Cover, Shoe, Operating-Room | Class 1 | NON-Skid Shoe Cover | 1995 | 176 |
| Device, Fixation, Tracheal Tube | Class 1 | Tracheal tube fixation device | 2011 | 46 |
| Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | Class 2 | Drape Sheet | 2022 | 2 |
| Drape, Surgical, Antimicrobial | Class 2 | Surgical Drapes, Surgical Dapes | 2009 | 39 |
| Drape, Surgical, Exempt | Class 2 | surgical drape | 2017 | 107 |
| Dressing, Compression | Class 1 | Dressing Compression | 2013 | 87 |
| Dressing, Wound, Drug | Class U | Dressing | 2026 | 48 |
| Dressing, Wound, Hydrophilic | Class 1 | Hydrophilic Dressing Wound | 2024 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Dressing Wound | 2024 | 183 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Electrosurgical, Cutting | 2024 | 65 |
| Fiber, Medical, Absorbent | Class 1 | Absorbent Towel | 2015 | 172 |
| General Surgery Tray | Class 2 | Universal I Pack | 2010 | 24 |
| Gown, Examination | Class 1 | LAB Jacket | 1998 | 109 |
| Gown, Surgical | Class 2 | PP Gown, Prevention Plus gown, PRABADIN / Surgical gown, Gown, L2 and L3 surgical gowns, L4 surgical gowns and 1 more | 2009 | 68 |
| Mask, Surgical | Class 2 | Surgical mask with Fluid Shield, Surgical mask, Face Mask | 2008 | 125 |
| Non-Surgical Gown | Class 1 | PE Coated Gowns | 2009 | 318 |
| Plastic Surgery And Accessories Kit | Class 1 | Accessories Kit | 2026 | 2 |
| Respirator, Surgical | Class 2 | N95 Particulate Respirator, Particulate Respirator | 2021 | 118 |
| Suit, Surgical | Class 1 | Scrubs, Coverall, LAB Coat, LAB Jacket | 2007 | 74 |
| Surgical Instruments, G-U, Manual (And Accessories) | Class 1 | surgical instrument | 2011 | 5 |
| Table, Cysto, Non-Electrical | Class 1 | Drain BAG Pouch | 2013 | 4 |
| Tray, Surgical | Class 1 | General Surgery Tray | 2024 | 36 |
| Tray, Surgical, Needle | Class 1 | Surgical Needle Tray | 2024 | 1 |
| Wrap, Sterilization | Class 2 | Sterilization Wrap | 2011 | 38 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Master& Frank | MSH | 1 |
Clearances
2 clearances name Dongguan Shin YI Healthcare Products Factory 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 |
|---|---|---|---|---|
| K230610 | 2023-08-23 | FYA | Traditional | This company |
| K210372 | 2021-06-07 | FXX | Traditional | This company |
| K172963 | 2018-04-04 | MSH | Traditional | Master & Frank Enterprise Co., Ltd. |
Nearby Manufacturers
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.