FDA Registration
Active
🇹🇭 Thailand
Novum IQ Large Volume Pump
Reg #: 3005700264
·
FEI: 3005700264
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Orbray (Thailand) Co. Ltd.
- Registration Number
- 3005700264
- FEI Number
- 3005700264
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 60/29 M. 4 T. Banklang
- City
- Muang Lamphun
- Country
- TH
Regulatory Submissions
- 510(k) Number
- K211122
Owner / Operator
- Firm Name
- Orbray (Thailand) Co., Ltd.
- Operator Number
- 10085909
- Address
- 60/29 M. 4 T. Banklang
- City
- Muang
- State
- Lamphun
- Postal Code
- 51000
- Country
- TH
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2024-04-03 |
Proprietary Names
Novum IQ Large Volume Pump
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)