FDA Registration
Active
🇹🇼 Taiwan
INNOVATIVE MEDICAL MANUFACTURING CO.
Reg #: 3003974574
·
FEI: 3003974574
·
Expires 2026
Products
17
Proprietary Names
9
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- INNOVATIVE MEDICAL MANUFACTURING CO.
- Registration Number
- 3003974574
- FEI Number
- 3003974574
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 107, LN 181, SEC 1,, Yongzhen Rd.,
- City
- Zhunan Township, Miaoli County
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K070801
Owner / Operator
- Firm Name
- INNOVATIVE MEDICAL MANUFACTURING CO.
- Operator Number
- 9076256
- Address
- No.107, LANE 181, Sec. 1,, Yongzhen Rd.,
- City
- Zhunan Township, Miaoli County
- State
- TW-NOTA
- Postal Code
- 35057
- Country
- TW
- Correspondent
- CHUNG-PING - LEE
US Agent
- Business Name
- David
- Contact Name
- David McCool
- Address
- 36330 Hidden Springs Rd.,, Suite E
- City
- Wildomar
- State
- CA
- ZIP
- 92595
- Country
- US
- [email protected]
- Phone
- 714 3480456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-12-31 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2012-10-19 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2020-10-18 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2016-05-16 |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | Class 2 | Hematology | No | 2019-07-16 |
| Esthesiometer | GXB | Class 1 | Neurology | No | 2017-08-07 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2014-12-03 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2018-06-27 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2023-12-13 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2005-08-10 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2010-10-18 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2020-09-01 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2010-01-24 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-08-16 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2020-10-18 |
| Introducer, Syringe Needle | KZH | Class 2 | General Hospital | No | 2022-10-30 |
| Adaptor, Catheter | GCE | Class 1 | General, Plastic Surgery | No | 2019-01-03 |
Proprietary Names
Gastroenterology/Urology, URINARY CATHETER
Urinary Catheter
"Puriblood" Leukocyte Reduction Filtration System for Red Blood Cells
PAV luer lock device
Intravenous Tubing Set
Needleless access device
"IMM" Hypodermic needle set
Blunt Cannula Assembly
Vial Access Subassembly
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198