FDA Registration
Active
🇨🇳 China
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
Reg #: 3010806467
·
FEI: 3010806467
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
- Registration Number
- 3010806467
- FEI Number
- 3010806467
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 101, 201, 301, Bldg 38,Xialang Industrial Area,Heshuikou,, Matian Street, Guangming District
- City
- ShenZhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K141594
Owner / Operator
- Firm Name
- Unimicro Medical Systems (Shenzhen) Co., Ltd.
- Operator Number
- 10046262
- Address
- 101, 201, 301, Bldg 38,Xialang Industrial Area,Heshuikou, Matian Street,Guangming District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518106
- Country
- CN
- Correspondent
- Xinfeng Chen
US Agent
- Business Name
- Shenzhen Joyantech Consulting Co., Ltd.
- Contact Name
- Thomas Tang
- Address
- 25 Hopewell Drive Stony Brook
- City
- Stony Brook
- State
- NY
- ZIP
- 11790
- Country
- US
- [email protected]
- Phone
- 631 7511103
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2015-10-15 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2014-09-02 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2015-10-15 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2015-10-15 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2015-04-22 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2014-02-25 |
Proprietary Names
Trocar Kit ATR Series, BTR Series, VTR Series, HTR Series, STR Series, UNTR Series, UNTB Series, 1TR Series
Auto Retrieval Pouch
Insufflation Tubing Set
Veress Needle MND11200, MND11500
Monopolar Laparoscopic Accessories
Suction Irrigation Set
Suction Irrigation Set with Smoke Filter
Smoke Filter
Establishment Types
Manufacture Medical Device