FDA Registration
Active
🇨🇦 Canada
Arjo Canada Inc.
Reg #: 3010010434
·
FEI: 3010010434
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- Arjo Canada Inc.
- Registration Number
- 3010010434
- FEI Number
- 3010010434
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 550 Matheson Blvd. East, Unit 7
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K001079
Owner / Operator
- Firm Name
- ArjoHuntleigh AB
- Operator Number
- 10036598
- Address
- Hans Michelsensgatan 10
- City
- Malmo
- State
- Skane
- Postal Code
- 211 20
- Country
- SE
US Agent
- Business Name
- Arjo Inc
- Contact Name
- Darren Demerritt
- Address
- 2000 Center Drive, Suite D403
- City
- Hoffman Estates
- State
- IL
- ZIP
- 60192
- Country
- US
- [email protected]
- Phone
- 425 3089587
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bath, Hydro-Massage | ILJ | Class 2 | Physical Medicine | No | 2020-06-10 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2011-05-17 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2020-06-05 |
| Bed, Flotation Therapy, Powered | IOQ | Class 2 | Physical Medicine | No | 2019-11-28 |
Proprietary Names
HARMONIE (FOREIGN EXPORTER)
SYSTEM 2000 (FOREIGN EXPORTER)
SARA PLUS (FOREIGN EXPORTER ONLY)
Various Arjo slings
Arjo Disposable Slide sheets; Arjo Disposable Slide Tube
CITADEL PATIENT CARE SYSTEM (BED FRAME AND MATTRESS)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device