FDA Registration
Active
🇵🇱 Poland
KINAIR MEDSURG (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
Reg #: 3007420694
·
FEI: 3007420694
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
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 |
|---|---|---|---|---|---|
| Bed, Flotation Therapy, Powered | IOQ | Class 2 | Physical Medicine | No | 2003-08-11 |
Proprietary Names
KINAIR MEDSURG (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
KINAIR IV (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
CITADEL PATIENT CARE SYSTEM (BED FRAME AND MATTRESS) (POZNAN - MFR & COMPLAINTS)
THERAPULSE (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
BARIAIR (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
THERAPULSE ATP (SPEC. DEVELOPER & COMPLAINTS)
SKIN IQ MCM (POZNAN - COMPLAINTS)
SKIN IQ 1000 (POZNAN - COMPLAINTS)
SKIN IQ 365 (POZNAN - COMPLAINTS)
Establishment Types
Complaint File Establishment per 21 CFR 820.198