FDA Registration
Active
🇳🇿 New Zealand
OPUM TECHNOLOGIES SERVICES
Reg #: 3015766032
·
FEI: 3015766032
·
Expires 2026
Products
1
Proprietary Names
11
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OPUM TECHNOLOGIES SERVICES
- Registration Number
- 3015766032
- FEI Number
- 3015766032
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- University of Auckland Newmarket Campus, Building 903, 314-390 Khyber Pass Road, Newmarket, Auckland, 1023 , N, Khyber Pass Road,
- City
- Newmarket Auckland
- Country
- NZ
Owner / Operator
- Firm Name
- OPUM TECHNOLOGIES SERVICES LIMITED
- Operator Number
- 10089032
- Address
- University of Auckland Newmarket Campus, Building 903, 314-390 Khyber Pass Road, Newmarket
- City
- Auckland
- State
- NZ-AUK
- Postal Code
- 1023
- Country
- NZ
- Correspondent
- Alexandra J Wilson
US Agent
- Business Name
- OPUM US INC
- Contact Name
- David Smith
- Address
- 1160 Battery St Ste 100 # 1066
- City
- San Francisco
- State
- CA
- ZIP
- 94111
- Country
- US
- [email protected]
- Phone
- 925 9893885
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Goniometer, Ac-Powered | KQX | Class 1 | Orthopedic | No | 2023-10-30 |
Proprietary Names
Digital Knee DK-013
Digital Knee DK-011
Digital Knee DK-015
Digital Knee DK-014
Digital Knee DK-010
Digital Knee DK-008
Digital Knee DK-016
Digital Knee DK-009
Digital Knee DK-012
myDigitalKnee App
Digital Knee Sensor DK-017
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device