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
Phone
425 3089587

Products

Device Name Product Code
Lift, Patient, Non-Ac-Powered FSA
Aid, Transfer IKX
Bed, Flotation Therapy, Powered IOQ
Sleeve, Limb, Compressible JOW
Device, Transfer, Patient, Manual FMR

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