FDA Registration
Active
🇵🇭 Philippines
INTEGRATED MICRO-ELECTRONICS INC. (IMI)
Reg #: 3013294311
·
FEI: 3013294311
·
Expires 2026
Products
4
Proprietary Names
28
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- INTEGRATED MICRO-ELECTRONICS INC. (IMI)
- Registration Number
- 3013294311
- FEI Number
- 3013294311
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- North Science Avenue, Laguna Technopark-Special Economic Zone (LT-SEZ)
- City
- Binan Laguna
- Country
- PH
Owner / Operator
- Firm Name
- INTEGRATED MICRO-ELECTRONICS INC. (IMI)
- Operator Number
- 10058003
- Address
- NORTH SCIENCE AVENUE, LAGUNA TECHNOPARK-SPECIAL ECONOMIC ZONE (LT-SEZ)
- City
- Binan
- State
- Laguna
- Postal Code
- 4024
- Country
- PH
- Correspondent
- Isabel Restivo
US Agent
- Business Name
- WS Audiology USA, Inc.
- Contact Name
- Isabel Restivo
- Address
- 101 wood avenue south, 7th Floor
- City
- Iselin
- State
- NJ
- ZIP
- 08830
- Country
- US
- [email protected]
- Phone
- 551 5799581
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Masker, Tinnitus | KLW | Class 2 | Ear, Nose, Throat | No | 2018-06-24 |
| Self-Fitting Air-Conduction Hearing Aid, Prescription | QDD | Class 2 | Ear, Nose, Throat | No | 2022-08-24 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2018-06-24 |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | Class 2 | Ear, Nose, Throat | No | 2024-05-01 |
Proprietary Names
Signia Intuis
Signia IX
Signia Insio
Rexton Emerald
Signia Pure
Signia AX
Insio Charge&Go
Signia Styletto
Intuis 3
Intuis 4
Signia Motion
CROS AX
Pure Charge&Go
Signia Silk
Insio IX
Signia CROS
Styletto AX
Signia Ace
Motion Charge&Go
hear.com
Rexton BiCore
Signia Pure Charge&Go
Widex Moment Sheer
ALLURE
Widex Moment
Widex SmartRIC
Horizon Mini IX
Widex CROS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)