Changzhou Yonghua Medical Instruments Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 8 device types, 3 products catalogued.
Changzhou Yonghua Medical Instruments Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Broach, Reamer and 6 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | CHANGZHOU YONGHUA MEDICAL INSTRUMENTS CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012863589 |
| FEI number | 3012863589 |
| DUNS | 421329873 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 常州永华医疗器械有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.28 Changfan Road |
| Postal code | 213100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Broach | Class 1 | Yonghua | 2021 | 12 |
| Forceps | Class 1 | Yonghua | 2021 | 99 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | Yonghua | 2018 | 14 |
| Orthopedic Manual Surgical Instrument | Class 1 | Yonghua | 2016 | 53 |
| Orthosis, Spinal Pedicle Fixation | Class 2 | Yonghua | 2019 | 13 |
| Orthosis, Spondylolisthesis Spinal Fixation | Class 2 | Yonghua | 2019 | 13 |
| Reamer | Class 1 | Yonghua | 2021 | 23 |
| Tray, Surgical, Instrument | Class 1 | Yonghua | 2018 | 105 |
Own-Brand Listings
Clearances
No clearance names Changzhou Yonghua Medical Instruments Co., Ltd. as applicant. 3 are held by other companies 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 |
|---|---|---|---|---|
| K160076 | 2016-10-13 | MAX | Traditional | Ouroboros Medical |
| K133514 | 2014-05-01 | MAX | Traditional | Ouroboros Medical |
| K061600 | 2006-08-22 | MNI | Traditional | Life Spine |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Employees | 300+ |
| Factory area | 30,118 square meters total construction; 25,888 square meters land coverage |
| Main products | Orthopedic surgical instruments, Implant OEM solutions, Instrument cases, Broken screw removal sets, External fixation systems |
| Certifications | ISO 9001, ISO 13485, CE |
| Export markets | Denmark, Germany, Romania, Italy, Spain, Serbia, South Africa, Canada, USA, Mexico, Brazil |
| OEM and ODM | Offered |
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.
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