Unimicro Medical Systems (Shenzhen) Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 6 device types, 25 products catalogued, 5 clearances.
Unimicro Medical Systems (Shenzhen) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Pneumoperitoneum Needle, Insufflator, Laparoscopic and 4 other device types. 25 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010806467 |
| FEI number | 3010806467 |
| DUNS | 421327368 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 联合微创医疗器械（深圳）有限公司 |
|---|---|
| Unified social credit code | 914403005763628992 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 101, 201, 301, Bldg 38,Xialang Industrial Area,Heshuikou, |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Monopolar Laparoscopic Accessories | 2015 | 65 |
| Insufflator, Laparoscopic | Class 2 | Veress Needle MND11200, MND11500 | 2015 | 10 |
| Laparoscope, General & Plastic Surgery | Class 2 | Trocar Kit ATR Series, BTR Series, VTR Series, HTR Series, STR Series, UNTR Series, UNTB Series, 1TR Series, Auto Retrieval Pouch, Suction Irrigation Set, Suction Irrigation Set with Smoke Filter | 2014 | 46 |
| Pneumoperitoneum Needle | Class 2 | Veress Needle MND11200, MND11500 | 2015 | 4 |
| Tube, Smoke Removal, Endoscopic | Class 1 | Smoke Filter | 2014 | 4 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | Class 1 | Insufflation Tubing Set | 2014 | 12 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K141594 | 2015-08-10 | GCJ | Traditional | This company |
| K150068 | 2015-07-31 | HIF | Traditional | This company |
| K142208 | 2015-04-13 | GEI | Traditional | This company |
| K141593 | 2014-11-13 | GCJ | Traditional | This company |
| K141592 | 2014-08-04 | GCJ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | Trocar cannula systems, Minimally invasive surgical instruments, Electronic endoscope series, Irrigation and suction devices, Specimen retrieval bags |
| Certifications | FDA, CE, TGA, ANVISA, GOST-R |
| Export markets | Over 70 countries globally |
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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