FDA Registration
Active
🇨🇦 Canada
Curve Image 2
Reg #: 3009246966
·
FEI: 3009246966
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CD Newco Canada Inc.
- Registration Number
- 3009246966
- FEI Number
- 3009246966
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 700 2 Street SW, Floor 19
- City
- Calgary Alberta
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K173101
Owner / Operator
- Firm Name
- CD Newco LLC
- Operator Number
- 10041953
- Address
- 700 2 Street SW, Floor 19
- City
- Calgary
- State
- Alberta
- Postal Code
- T2P 2W2
- Country
- CA
- Correspondent
- Olivier Mireault
US Agent
- Business Name
- CD Newco LLC
- Contact Name
- Olivier Mireault
- Address
- 1712 S East Bay Blvd Ste 350 Bldg 5
- City
- Provo
- State
- UT
- ZIP
- 84606
- Country
- US
- [email protected]
- Phone
- 888 9104376
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-02-21 |
Proprietary Names
Curve Image 2
Curve Image 2 PACS
Curve Imaging
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device