FDA Registration
Active
🇨🇦 Canada
Moves SLC
Reg #: 3020476987
·
FEI: 3020476987
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- LINAMAR INNOVATION HUB
- Registration Number
- 3020476987
- FEI Number
- 3020476987
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 750 Woodlawn Road West
- City
- Guelph Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K161420
Owner / Operator
- Firm Name
- Linamar Innovation Hub
- Operator Number
- 10082640
- Address
- 750 Woodlawn Road West
- City
- Guelph
- State
- Ontario
- Postal Code
- N1K 1G4
- Country
- CA
- Correspondent
- Julio Mendez
US Agent
- Business Name
- Compliance Consultants
- Contact Name
- Richard Keen
- Address
- 1151 Hope St
- City
- Stamford
- State
- CT
- ZIP
- 06907
- Country
- US
- [email protected]
- Phone
- 203 3292700
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2021-08-30 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2021-08-30 |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2021-08-30 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2021-08-30 |
Proprietary Names
Moves SLC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)