Changzhou Holymed Products Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 16 device types, 1 product catalogued, 3 clearances.
Changzhou Holymed Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bag, Ice, Cap, Surgical and 14 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
16device types registered with the FDA
1product
3510(k) clearances
Registration
| Registered name | CHANGZHOU HOLYMED PRODUCTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006891803 |
| FEI number | 3006891803 |
| DUNS | 559978934 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 常州合力迈德医疗用品有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | 525 CHANGWU ROAD SOUTH |
| Postal code | 213167 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Isolation Mask, Stethoscope Cover, Lab Coats, Coveralls, Barrier Sleeve, Scurb Shirts/Pants, scurb suit and 4 more | 2008 | 439 |
| Bag, Ice | Class 1 | ice bag | 2020 | 86 |
| Bedding, Disposable, Medical | Class 1 | Stretcher Cover, Infant shirt white, Baby blanket, Mastress sheet | 2018 | 308 |
| Brush, Scrub, Operating-Room | Class 1 | scurb suit | 2021 | 42 |
| Cap, Surgical | Class 1 | nonwoven caps,bouffant caps, surgical caps | 2008 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | shoe covers, boot covers, arm covers | 2008 | 176 |
| Drape, Surgical, Antimicrobial | Class 2 | drape,surgical,gown surgical, Drape, surgical | 2013 | 39 |
| Drape, Surgical, Exempt | Class 2 | 2017 | 107 | |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze / sponge | 2021 | 266 |
| General Surgery Tray | Class 2 | 2015 | 24 | |
| Gown, Examination | Class 1 | 2010 | 109 | |
| Gown, Surgical | Class 2 | surgical gown, drape,surgical,gown surgical | 2011 | 68 |
| Mask, Gas, Anesthetic | Class 1 | Mask, GAS, Anesthetic | 2009 | 71 |
| Mask, Surgical | Class 2 | Surgical mask | 2021 | 125 |
| Non-Surgical Gown | Class 1 | Ortho Shorts, Coveralls | 2008 | 318 |
| Shoe And Shoe Cover, Conductive | Class 1 | 2019 | 32 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Holymed | LYU | 28 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210524 | 2021-07-07 | FXX | Traditional | This company |
| K121998 | 2012-12-20 | FYA | Traditional | This company |
| K122000 | 2012-12-12 | KKX | Traditional | This company |
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.