FDA Registration
Active
🇵🇱 Poland
ArjoHuntleigh Polska Sp. zo.o.
Reg #: 3007420694
·
FEI: 3007420694
·
Expires 2026
Products
23
Proprietary Names
199
Establishment Types
5
Classifications
23
Registration Details
- Registration Name
- ArjoHuntleigh Polska Sp. zo.o.
- Registration Number
- 3007420694
- FEI Number
- 3007420694
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ul. Ks. Wawrzyniaka 2, Komorniki
- City
- Poznan Wielkopolskie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K930665
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
- 2000 Center Drive, 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 |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2007-12-05 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2013-10-29 |
| Bath, Hydro-Massage | ILJ | Class 2 | Physical Medicine | No | 2015-04-21 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2002-08-15 |
| Bed, Patient Rotation, Powered | IKZ | Class 2 | Physical Medicine | No | 2003-08-11 |
| Bed, Flotation Therapy, Powered | IOQ | Class 2 | Physical Medicine | No | 2003-08-11 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2015-04-21 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2015-04-21 |
| Washer Of Body Waste Receptacles | FLH | Class 1 | General Hospital | No | 2017-08-10 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2002-08-15 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2015-04-21 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2015-04-21 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2002-08-15 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2002-08-15 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2015-04-21 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2013-06-12 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2013-10-29 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2012-06-14 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2015-04-21 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2008-03-26 |
| Bed, Air Fluidized | INX | Class 2 | Physical Medicine | No | 2015-04-22 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2002-08-15 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2009-05-28 |
Proprietary Names
HYDROVEN GARMENTS (POZNAN - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)
HYDROVEN 3 PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)
HYDROVEN FPR PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)
LIFT WALKER (POZNAN - MFR & COMPLAINTS)
CENTURY (POZNAN - MFR, COMPLAINTS)
PRIMO (POZNAN - MFR, COMPLAINTS)
RHAPSODY (POZNAN - MFR, COMPLAINTS)
PRIMO SYSTEM 2000 (POZNAN - MFR, COMPLAINTS)
RHAPSODY SYSTEM 2000 (POZNAN - MFR, COMPLAINTS)
HARMONY (POZNAN - MFR, COMPLAINTS)
PRIMO FERRO (POZNAN - MFR, COMPLAINTS)
SYSTEM 2000 (POZNAN - MFR, COMPLAINTS)
BUBBLE PAD MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
ALPHA RESPONSE PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS)
NIMBUS 3 PUMP (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
BREEZE MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
ALPHA TRANCELL DELUXE PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS)
ACER PORTABLE LATERAL ROTATION SYSTEM (POZNAN - SPEC.DEVELOPER & POZNAN - COMPLAINTS)
BREEZE PUMP (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
FIRST STEP SELECT PUMP (SUZHOU - MANUFACTURER & POZNAN - COMPLAINTS)
THERAKAIR VISIO MATTRESS (POZNAN - COMPLAINTS)
AURA CUSHION (SUZHOU - MFR & POZNAN - COMPLAINTS)
FIRST STEP ALL IN ONE (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
FIRST STEP SELECT MATTRESSES (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
ALPHA RESPONSE MATTRESS (POZNAN - SPEC. DEVELOPER, POZNAN - COMPLAINTS)
AUTOLOGIC MATTRESS (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS)
THERAKAIR VISIO PUMP (POZNAN - COMPLAINTS)
NIMBUS 4 PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS)
NIMBUS 4 MATTRESS ASSEMBLY RELIANT IS2 (SUZHOU - MFR & POZNAN - COMPLAINTS)
PROFICARE (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
AURA PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS)
FIRST STEP CIRRUS OVERLAY (SUZHOU - MFR & POZNAN - COMPLAINTS)
NIMBUS PRO MATTRESS (SUZHOU - MFR & POZNAN - COMPLAINTS)
MAXXAIR ETS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
ATMOSAIR 9000AR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
NIMBUS 3 MATTRESS (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
AUTOLOGIC PUMP (SUZHOU - SPEC.DEV & POZNAN - COMPLAINTS)
CITADEL CONTROL UNIT AND MATTRESS (SUZHOU - SPEC. DEVELOPER & MANUFACTURER, POZNAN - COMPLAINTS, POZNAN - FOREIGN EXP)
ATMOSAIR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
FIRST STEP PLUS (SUZHOU - MFR & POZNAN - COMPLAINTS)
ATMOSAIR 9000A (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
ATMOSAIR APOD (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
FIRST STEP SELECT HD (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS)
AURALIS PUMP (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS)
AURALIS MATTRESSES (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS)
ATMOSAIR VELARIS MATTRESSES (POZNAN MFR, POZNAN COMPLAINTS)
ATMOSAIR VELARIS PUMP (SUZHOU MFR, POZNAN COMPLAINTS)
CAYLIS PUMP (SUZHOU MFR, POZNAN COMPLAINTS); CAYLIS MATTRESSES (SUZHOU MFR, POZNAN COMPLAINTS)
TRIADYNE PROVENTA (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
ROTOPRONE (POZNAN - COMPLAINTS)
ROTOREST (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
THERAPULSE ATP (SPEC. DEVELOPER & COMPLAINTS)
KINAIR MEDSURG (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
SKIN IQ 365 (POZNAN - COMPLAINTS)
BARIAIR (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
CITADEL PATIENT CARE SYSTEM (BED FRAME AND MATTRESS) (POZNAN - MFR & COMPLAINTS)
SKIN IQ 1000 (POZNAN - COMPLAINTS)
THERAPULSE (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
KINAIR IV (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
SKIN IQ MCM (POZNAN - COMPLAINTS)
Various Arjo Baths (POZNAN FOREIGN EXPORTER)
SYMBLISS BATH (POZNAN - MFR & COMPLAINTS)
PATIENT HELPER FIXED LIFTING POLE (POZNAN - SPEC DEVELOPER & COMPLAINTS)
PATIENT HELPER ROTATING LIFTING POLE (POZNAN - SPEC DEVELOPER & COMPLAINTS)
PATIENT HELPER BARIATRIC LIFTING POLE (POZNAN - SPEC DEVELOPER & COMPLAINTS)
PATIENT HELPER FULL TRACTION FRAME (POZNAN - SPEC DEVELOPER & COMPLAINTS)
FLOWTRON ACS800 PUMP OPERATING ROOM VARIANT (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS)
FLOWTRON ACS800 PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS)
TRI PULSE GARMENTS TRP10, TRP20, TRP30, TRP40 & TRP60L (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)
SHOWER PANEL W/SINK (POZNAN - MFR. COMPLAINTS)
PRELUDE SHOWER CABINET (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
SHOWER PANEL (POZNAN - MFR. COMPLAINTS)
FLUSH SINK (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER)
TORNADO (POZNAN - MFR AND COMPLAINTS)
TYPHOON (POZNAN - MFR AND COMPLAINTS)
NINJO (POZNAN - MFR AND COMPLAINTS)
AMIGO (POZNAN - COMPLAINTS)
ENTERPRISE 9000 SERIES (POZNAN - COMPLAINTS)
ENTERPRISE 9700X (POZNAN - MFR & COMPLAINTS)
MINUET 2 (POZNAN - MFR & COMPLAINTS)
BARIMAXX ACTIVE (POZNAN SPEC. DEVELOPER & COMPLAINTS)
BARIMAXX II (POZNAN SPEC. DEVELOPER & COMPLAINTS)
CONTOURA 1080 (POZNAN - MFR & COMPLAINTS)
ENTERPRISE 9600X (POZNAN - MFR & COMPLAINTS)
ENTERPRISE 9800X (POZNAN - MFR & COMPLAINTS)
CITADEL PLUS BARIATRIC BED FRAME SYSTEM (POZNAN - MFR & COMPLAINTS)
CITADEL BED FRAME (POZNAN - MFR & COMPLAINTS)
ENTERPRISE 9000X (POZNAN - MFR & COMPLAINTS)
EVENDA BED (POZNAN - MFR & COMPLAINTS)
ENTERPRISE 5000X (POZNAN - MFR & COMPLAINTS)
ENTERPRISE 8000X (POZNAN - MFR & COMPLAINTS)
MAXIAIR PUMP (POZNAN - COMPLAINTS ONLY)
MAXIAIR TRANSFER MATTRESS (POZNAN - COMPLAINTS ONLY)
AIRPAL AIR SUPPLY (POZNAN - MFR, POZNAN - COMPLAINTS)
MULTICLEAN (POZNAN - MFR, COMPLAINTS)
ATMOSAIR CUSHION (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
Hydroven 12 Garments (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS, POZNAN - CONTRACT MFR)
Hydroven 12 Pump (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS,SUZHOU- CONTRACT MFR)
DISPOSABLE REPOSITIONING SLING (POZNAN - COMPLAINTS)
CAREVO (POZNAN - MFR & COMPLAINTS)
BOLERO (POZNAN - MFR & COMPLAINTS)
SARA 3000 (POZNAN - MFR & COMPLAINTS)
MAXI SKY 2 (POZNAN COMPLAINTS ONLY)
ALENTI & MIRANTI BELTS/STRAPS (POZNAN - MFR & COMPLAINTS)
MIRANTI (POZNAN - MFR & COMPLAINTS)
MAXI LITE (POZNAN COMPLAINTS ONLY)
MAXI MOVE (POZNAN COMPLAINTS ONLY)
VARIOUS STRETCHER SLINGS (POZNAN - COMPLAINTS)
MAXI SKY 600 (POZNAN COMPLAINTS ONLY)
ACTIVE AND REPOSITIONING SLINGS (POZNAN - COMPLAINTS)
CARINO (POZNAN - MFR & COMPLAINTS)
ALENTI (POZNAN - MFR & COMPLAINTS)
MAXI SKY 1000 (POZNAN COMPLAINTS ONLY)
WALKING JACKET (POZNAN COMPLAINTS ONLY)
LOOP COMFORT REPOSITIONING SLING (POZNAN - MFR & COMPLAINTS)
CONCERTO (POZNAN - MFR & COMPLAINTS)
CALYPSO (POZNAN - MFR & COMPLAINTS)
MAXI SKY 440 (POZNAN COMPLAINTS ONLY)
MAXI 500 (POZNAN COMPLAINTS ONLY)
SARA PLUS (POZNAN - MFR & COMPLAINTS)
VOYAGER DUO (POZNAN COMPLAINTS ONLY)
TENOR (POZNAN - MFR & COMPLAINTS)
CARENDO (POZNAN - MFR & COMPLAINTS)
VARIOUS STANDING & TRANSFER SLINGS(POZNAN - COMPLAINTS)
VOYAGER PORTABLE (POZNAN COMPLAINTS ONLY)
MAXI TWIN (POZNAN - MFR & COMPLAINTS)
SARA LITE (POZNAN COMPLAINTS ONLY)
VARIOUS CLIP & LOOP SLINGS (DISPOSABLE & NON-DISPOSABLE) - (POZNAN - COMPLAINTS)
MAXI SKY 2 PLUS (POZNAN COMPLAINTS ONLY)
VARIOUS FLITE (DISPOSABLE) 4PT LOOP SLINGS (POZNAN - COMPLAINTS)
SARA FLEX (POZNAN COMPLAINTS ONLY)
VARIOUS 4PT LOOP (FABRIC) REUSABLE SLINGS (POZNAN - COMPLAINTS)
VARIOUS FLITE (DISPOSABLE) 4PT CLIP SLINGS (POZNAN - COMPLAINTS)
VARIOUS REPOSITIONING SLINGS (POZNAN - COMPLAINTS)
VARIOUS 4PT CLIP (FABRIC) REUSABLE SLINGS (POZNAN - COMPLAINTS)
MAXI TWIN COMPACT (POZNAN - MFR & COMPLAINTS)
VIPER (POZNAN-MFR & COMPLAINTS)
C-HOOK SLING (POZNAN - MFR & COMPLAINTS)
MAXI MOVE 5 (POZNAN COMPLAINTS ONLY)
LOOP AMBULATION SLING (POZNAN COMPLAINTS ONLY)
SYMBLISS BATH CHAIR (POZNAN - MFR & COMPLAINTS)
MINSTREL (POZNAN - MFR & COMPLAINTS)
SARA STEDY (POZNAN - COMPLAINTS ONLY)
SARA STEDY COMPACT (POZNAN - COMPLAINTS ONLY)
FLOWTRON ACS900 PUMP OPERATING ROOM (SUZHOU- MFR., POZNAN - COMPLAINTS)
FLOWTRON ACS900 PUMP (SUZHOU - MFR., POZNAN - COMPLAINTS)
CARINO BED PAN (POZNAN - MFR & COMPLAINTS)
ALENTI BED PAN (POZNAN - MFR & COMPLAINTS)
CARMINA BED PAN (POZNAN - MFR & COMPLAINTS)
CARMINA (POZNAN - MFR & COMPLAINTS)
DVT 60L BARIATRIC GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)
FREEDOM BATH (POZNAN - MFR, COMPLAINTS)
SEBA LEGLIFT (POZNAN - COMPLAINTS)
ARJO PULL STRAPS FOR SLIDE SHEETS (POZNAN - MFR & COMPLAINTS)
ARJO SLIDE TUBE (POZNAN - MFR & COMPLAINTS)
ARJO SLIDE SHEETS (DISPOSABLE) (POZNAN - MFR & COMPLAINTS)
ARJO SLIDE SHEETS (NON-DISPOSABLE) (POZNAN - MFR & COMPLAINTS)
ARJO SLIDE FLITES (POZNAN-COMPLAINTS)
RIK FOOT HUGGER (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
RIK OR PAD (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
FLOWTRON EXCEL PUMP (SUZHOU SPEC.DEV, POZNAN - COMPLAINTS)
DVT20 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)
L501-M GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)
DVT30 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)
DVT10 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)
DVT40 GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)
L503-M GARMENT (POZNAN - SPEC. DEV., MFR. & COMPLAINTS)
FG200-R LARGE FOOT GARMENT (POZNAN - MFR & COMPLAINTS)
FG100-R REGULAR FOOT GARMENT (POZNAN - MFR & COMPLAINTS)
FLOWTRON UNIVERSAL AC600 PUMP (POZNAN - COMPLAINTS)
FLOWTRON UNIVERSAL AC600OR PUMP (POZNAN - COMPLAINTS)
ATMOSAIR 4000 (POZNAN SPEC. DEVELOPER & COMPLAINTS)
ATMOSAIR FIT MATTRESS SYSTEM (POZNAN COMPLAINTS)
THERAREST SMS (POZNAN MANUFACTURER & COMPLAINTS)
RIK OVERLAY (POZNAN SPEC. DEVELOPER & COMPLAINTS)
PRESSURE IQ EVOLVE (POZNAN SPEC. DEVELOPER & COMPLAINTS)
ATMOSAIR STRETCHER (POZNAN SPEC. DEVELOPER & COMPLAINTS)
ATMOSAIR M-SERIES (POZNAN SPEC. DEVELOPER & COMPLAINTS)
ATMOSAIR T-SERIES (POZNAN SPEC. DEVELOPER & COMPLAINTS)
ATMOSAIR V-SERIES (POZNAN SPEC. DEVELOPER & COMPLAINTS)
ATMOSAIR PLUS MATTRESS SYSTEM (POZNAN SPEC. DEVELOPER & COMPLAINTS)
ATMOSAIR 9000 (POZNAN SPEC. DEVELOPER & COMPLAINTS)
RIK (POZNAN SPEC. DEVELOPER & COMPLAINTS)
THERAREST PERIMETER PLUS (POZNAN MANUFACTURER & COMPLAINTS)
ATMOSAIR A-SERIES (POZNAN SPEC. DEVELOPER & COMPLAINTS)
RIK MATTRESS (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
FTS (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
SIMULFLEX (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER)
CONFORMX (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER)
PENTAFLEX (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER)
ATMOSAIR 9000X (POZNAN MANUFACTURER & COMPLAINTS)
FLUIDAIR ELITE (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
FLUIDAIR ( POZNAN - SPEC. DEVELOPER & COMPLAINTS)
PARKER 500 (POZNAN - MFR, COMPLAINTS)
SARA COMBILIZER (POZNAN - MFR & COMPLAINTS)
LIFEGUARD 55 (POZNAN - MFR & COMPLAINT
LIFEGUARD 50 (POZNAN - MFR & COMPLAINTS)
LIFEGUARD 20 (POZNAN - MFR & COMPLAINTS)
FLOWTRON DVT5 GARMENT (POZNAN - MFR & COMPLAINTS)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility