FDA Registration
Active
🇩🇴 Dominican Republic
Arjo Dominican Republic
Reg #: 3012292104
·
FEI: 3012292104
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- Arjo Dominican Republic
- Registration Number
- 3012292104
- FEI Number
- 3012292104
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 9 PIISA Industrial Park, Km. 18 1/2 Antigua Carretera Sanchez
- City
- Itabo, Haina San Cristobal
- Country
- DO
Regulatory Submissions
- 510(k) Number
- K961166
Owner / Operator
- Firm Name
- ArjoHuntleigh AB
- Operator Number
- 10051620
- 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 Est
- State
- IL
- ZIP
- 60192
- Country
- US
- [email protected]
- Phone
- 425 3089587
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2016-04-12 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2019-10-31 |
| Bed, Flotation Therapy, Powered | IOQ | Class 2 | Physical Medicine | No | 2016-04-12 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2019-03-21 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2016-04-12 |
Proprietary Names
ACTIVE AND REPOSITIONING SLINGS
VARIOUS FLITE (DISPOSABLE) 4PT CLIP SLINGS
DISPOSABLE REPOSITIONING SLING
VARIOUS FLITE (DISPOSABLE) 4PT LOOP SLINGS
VARIOUS CLIP & LOOP SLINGS (DISPOSABLE & NON-DISPOSABLE)
VARIOUS 4PT LOOP (FABRIC) REUSABLE SLINGS
VARIOUS REPOSITIONING SLINGS
VARIOUS STRETCHER SLINGS
VARIOUS STANDING & TRANSFER SLINGS
VARIOUS 4PT CLIP (FABRIC) REUSABLE SLINGS
LOOP AMBULATION SLING
Arjo Disposable Slide Tube
Arjo Disposable Slide sheets
SKIN IQ 1000
SKIN IQ 365
SKIN IQ MCM
DVT40
DVT30
MAXIAIR TRANSFER MATTRESS
AIRPAL TRANSFER MATTRESS
AIRPAL DISPOSABLE SLING MATTRESS
Establishment Types
Manufacture Medical Device