FDA Registration
Active
🇹🇼 Taiwan
UNIMAX MEDICAL SYSTEMS INC.
Reg #: 3007791595
·
FEI: 3007791595
·
Expires 2026
Products
12
Proprietary Names
7
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- UNIMAX MEDICAL SYSTEMS INC.
- Registration Number
- 3007791595
- FEI Number
- 3007791595
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8F-2, No. 127, Lane 235, Pao Chiao Rd, Xindian District
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K111622
Owner / Operator
- Firm Name
- Unimax Medical Systems Inc.
- Operator Number
- 10028682
- Address
- 8F-2, No 127, Lane 235, Pao Chiao Rd, Xindian District
- City
- New Taipei City
- State
- TW-TPE
- Postal Code
- 231
- Country
- TW
US Agent
- Business Name
- ProMedic, LLC
- Contact Name
- Matthew Dryden
- Address
- 131 Bay Point Dr NE
- City
- St Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ring (Wound Protector), Drape Retention, Internal | KGW | Class 2 | General, Plastic Surgery | No | 2019-07-25 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2011-09-15 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2011-10-18 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2011-12-25 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2011-03-29 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2010-11-30 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2014-05-26 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2011-08-25 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2011-08-25 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2009-10-02 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2010-08-16 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2009-07-13 |
Proprietary Names
Wound Retractor
Suction Liner
Irrigation Pump
Veress Needle
Suction Irrigation Set
Smoke Evacuation Tubing
Insufflation Tubing Set
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility