Data / Medical devices / China / Excellent Medical Technology Group Co., Ltd.
Excellent Medical Technology Group Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Excellent Medical Technology Group Co., Ltd. is registered with the FDA (registration 3018058145) in Suzhou Jiangsu, China. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 3, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3018058145
- Address
- Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road, Xiangcheng District, Suzhou Jiangsu, China, 215131
- Owner or operator
- Excellent Medical Technology Group Co., Ltd. (10082410)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- July 24, 2021
- Registered through
- 2026
- Brand names listed
- Adult Diaper, Diaper, Diaper for incontinence, disposable pants for incontinence, Drape, Surgical drape, operation drape, towel drape, Gowns, surgical; AAMI Lever 3 Protection Gowns for surgeon, Ice bags, Bags for Ice containing, Non-Surgical Isolation Gown, Isolation gown, liquid Isolation gown, Stockinette, Stockinette tube,, Underpad, bedding sheet, super-absorbent underpad, medical absorbent pad,, cold pack; pack for ice
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Ice | KYR | 1 | Exporter to the US | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Exporter to the US | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| June 3, 2022 | K220665 | Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile | FYA | Substantially Equivalent | Excellent Medical Technology Group Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bag, Ice
- All makers of Bedding, Disposable, Medical
- All makers of Drape, Surgical, Exempt
- All makers of Garment, Protective, For Incontinence
- All makers of Gown, Surgical
- All makers of Bandage, Elastic
Updated June 3, 2022. 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.