FDA Registration
Active
🇨🇦 Canada
HALIFAX BIOMEDICAL INC.
Reg #: 3007305589
·
FEI: 3007305589
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HALIFAX BIOMEDICAL INC.
- Registration Number
- 3007305589
- FEI Number
- 3007305589
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10984 Highway 19
- City
- Mabou Nova Scotia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K103417
Owner / Operator
- Firm Name
- Halifax Biomedical Inc.
- Operator Number
- 10027189
- Address
- 10984 Highway 19
- City
- Mabou
- State
- Nova Scotia
- Postal Code
- B0E1X0
- Country
- CA
US Agent
- Business Name
- SpotOn Marketing Communications
- Contact Name
- Doreen Smillie
- Address
- 9121 Two Rod Rd
- City
- Hammondsport
- State
- NY
- ZIP
- 14840
- Country
- US
- [email protected]
- Phone
- 760 8460599
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2011-11-15 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2019-05-10 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-05-10 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2019-05-10 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2010-09-07 |
Proprietary Names
Tantalum Bead Set
Tantalum Bead Set - Sterile
TA Bead Set - Sterile
Halifax Imaging Kit
SR Suite
Halifax Bead Inserter
Halifax Bead Inserter Kit
Model Based - RSA Software
MBRSA Software
Establishment Types
Manufacture Medical Device