FDA Registration
Active
🇻🇳 Vietnam
Digitrapper pH Z
Reg #: 3007662958
·
FEI: 3007662958
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Given Imaging Vietnam Co., Ltd.
- Registration Number
- 3007662958
- FEI Number
- 3007662958
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Suite 6A, 6 floor, Standard Factory Bldg., 14th Street, Tan Thuan EPZ, Tan Thuan Dong Ward
- City
- Ho Chi Minh City
- Country
- VN
Owner / Operator
- Firm Name
- GIVEN IMAGING INC.
- Operator Number
- 10091555
- Address
- 15 HAMPSHIRE STREET
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
- Correspondent
- AVISHAG METZER
US Agent
- Business Name
- Medtronic, Inc.
- Contact Name
- Tania Pearson
- Address
- 710 Medtronic Pkwy
- City
- Minneapolis
- State
- MN
- ZIP
- 55432
- Country
- US
- [email protected]
- Phone
- 916 8138456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ph, Stomach | FFT | Class 1 | Gastroenterology, Urology | No | 2024-10-15 |
Proprietary Names
Digitrapper pH Z
Reflux software
AccuView pH & pH-Z software
Versaflex pH Z catheters
Versaflex pH catheters
pHersaflex pH catheters
Establishment Types
Manufacture Medical Device