FDA Registration
Active
🇵🇱 Poland
SHOWER PANEL W/SINK (POZNAN - MFR. COMPLAINTS)
Reg #: 3007420694
·
FEI: 3007420694
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
4
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 |
|---|---|---|---|---|---|
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2015-04-21 |
Proprietary Names
SHOWER PANEL W/SINK (POZNAN - MFR. COMPLAINTS)
FLUSH SINK (POZNAN - MFR, COMPLAINTS, FOREIGN EXPORTER)
PRELUDE SHOWER CABINET (POZNAN - SPEC. DEVELOPER & COMPLAINTS)
SHOWER PANEL (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
Export Device to the United States But Perform No Other Operation on Device