FDA Registration
Active
🇹🇼 Taiwan
UNIMAX MEDICAL SYSTEMS INC.
Reg #: 3015497424
·
FEI: 3015497424
·
Expires 2026
Products
12
Proprietary Names
7
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- UNIMAX MEDICAL SYSTEMS INC.
- Registration Number
- 3015497424
- FEI Number
- 3015497424
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 37, Sec. 2, Ligong 1st Rd., Wujie Township
- City
- Yilan County
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K103508
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
- Correspondent
- Jim Hsieh
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2011-12-25 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2009-07-13 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2011-08-25 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2011-08-25 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2010-08-16 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2014-05-26 |
| 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 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2009-10-02 |
| 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 |
Proprietary Names
Insufflation Tubing Set
Veress Needle
Wound Retractor
Smoke Evacuation Tubing
Suction Liner
Suction Irrigation Set
Irrigation Pump
Establishment Types
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)