Data / Medical devices / China / Jiangsu Haize Medical Scientific Development Co.,Ltd.
Jiangsu Haize Medical Scientific Development Co.,Ltd.: FDA-registered device maker in Wuxi Jiangsu, China, 2 510(k) clearances
Jiangsu Haize Medical Scientific Development Co.,Ltd. is registered with the FDA (registration 3010601984) in Wuxi Jiangsu, China. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010601984
- Address
- No.99, Furongzhongsan Road Xishan Economical Development Zone, Wuxi Jiangsu, China, 214192
- Owner or operator
- Jiangsu Haize Medical Scientific Development Co.,Ltd. (10045402)
- Roles
- Manufacturer
- First device listed
- November 12, 2013
- Registered through
- 2026
- Brand names listed
- ABSORBER, CARBON-DIOXIDE, ACCESSORY, SURGICAL APPAREL, CONTAINER, LIQUID MEDICATION, GRADUATED, MASK, SCAVENGING, RETRACTOR, Respirator, surgical, Single Use Surgical Suction Irrigator, ViClean and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Carbon-Dioxide | BSF | 1 | Manufacturer | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
| Ring (Wound Protector), Drape Retention, Internal | KGW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2023 | K230593 | Victan | GEI | Substantially Equivalent | Jiangsu Haize Medical Scientific Development Co., Ltd. | accessdata.fda.gov |
| June 24, 2016 | K161421 | Single Use Surgical Suction Irrigator | GCJ | Substantially Equivalent | Jiangsu Haize Medical Scientific Development Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Respirator, Surgical
- All makers of Mask, Scavenging
- All makers of Container, Liquid Medication, Graduated
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Retractor
Updated May 30, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.