FDA Registration
Active
🇵🇱 Poland
MAXI MOVE 5 (POZNAN COMPLAINTS ONLY)
Reg #: 3007420694
·
FEI: 3007420694
·
Expires 2025
Products
1
Proprietary Names
43
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ArjoHuntleigh Polska Sp. zo.o.
- Registration Number
- 3007420694
- FEI Number
- 3007420694
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ul. Ks. Wawrzyniaka 2, Komorniki
- City
- Poznan Wielkopolskie
- Country
- PL
Owner / Operator
- Firm Name
- ARJOHUNTLEIGH AB
- Operator Number
- 8010077
- 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
- 2349 W Lake St, #250
- City
- Addison
- State
- IL
- ZIP
- 60101
- 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 | 2002-08-15 |
Proprietary Names
MAXI MOVE 5 (POZNAN COMPLAINTS ONLY)
CAREVO (POZNAN - MFR & COMPLAINTS)
CARINO (POZNAN - MFR & COMPLAINTS)
SARA PLUS (POZNAN - MFR & COMPLAINTS)
VARIOUS STANDING & TRANSFER SLINGS(POZNAN - COMPLAINTS)
TENOR (POZNAN - MFR & COMPLAINTS)
CARENDO (POZNAN - MFR & COMPLAINTS)
LOOP COMFORT REPOSITIONING SLING (POZNAN - MFR & COMPLAINTS)
BOLERO (POZNAN - MFR & COMPLAINTS)
MIRANTI (POZNAN - MFR & COMPLAINTS)
MAXI SKY 440 (POZNAN COMPLAINTS ONLY)
VOYAGER DUO (POZNAN COMPLAINTS ONLY)
ALENTI (POZNAN - MFR & COMPLAINTS)
MAXI SKY 2 (POZNAN COMPLAINTS ONLY)
SARA 3000 (POZNAN - MFR & COMPLAINTS)
MAXI LITE (POZNAN COMPLAINTS ONLY)
VARIOUS CLIP & LOOP SLINGS (DISPOSABLE & NON-DISPOSABLE) - (POZNAN - COMPLAINTS)
SARA LITE (POZNAN COMPLAINTS ONLY)
CALYPSO (POZNAN - MFR & COMPLAINTS)
VARIOUS STRETCHER SLINGS (POZNAN - COMPLAINTS)
ALENTI & MIRANTI BELTS/STRAPS (POZNAN - MFR & COMPLAINTS)
MAXI SKY 1000 (POZNAN COMPLAINTS ONLY)
MAXI 500 (POZNAN COMPLAINTS ONLY)
WALKING JACKET (POZNAN COMPLAINTS ONLY)
MAXI SKY 2 PLUS (POZNAN COMPLAINTS ONLY)
ACTIVE AND REPOSITIONING SLINGS (POZNAN - COMPLAINTS)
MAXI MOVE (POZNAN COMPLAINTS ONLY)
VOYAGER PORTABLE (POZNAN COMPLAINTS ONLY)
MAXI TWIN (POZNAN - MFR & COMPLAINTS)
DISPOSABLE REPOSITIONING SLING (POZNAN - COMPLAINTS)
MAXI SKY 600 (POZNAN COMPLAINTS ONLY)
CONCERTO (POZNAN - MFR & COMPLAINTS)
SARA FLEX (POZNAN COMPLAINTS ONLY)
VARIOUS FLITE (DISPOSABLE) 4PT LOOP SLINGS (POZNAN - COMPLAINTS)
VARIOUS 4PT LOOP (FABRIC) REUSABLE SLINGS (POZNAN - COMPLAINTS)
MAXI TWIN COMPACT (POZNAN - MFR & COMPLAINTS)
VARIOUS 4PT CLIP (FABRIC) REUSABLE SLINGS (POZNAN - COMPLAINTS)
VARIOUS REPOSITIONING SLINGS (POZNAN - COMPLAINTS)
VARIOUS FLITE (DISPOSABLE) 4PT CLIP SLINGS (POZNAN - COMPLAINTS)
VIPER (POZNAN-MFR & COMPLAINTS)
C-HOOK SLING (POZNAN - MFR & COMPLAINTS)
MINSTREL (POZNAN - MFR & COMPLAINTS)
SYMBLISS BATH CHAIR (POZNAN - MFR & COMPLAINTS)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device