FDA Registration
Active
🇵🇱 Poland
CALYX MEDICAL Sp. Z.O.O.
Reg #: 3030450856
·
FEI: 3030450856
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- CALYX MEDICAL Sp. Z.O.O.
- Registration Number
- 3030450856
- FEI Number
- 3030450856
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 53-338 Wroclaw, ul. Wielka 31/2
- City
- Wroclaw Dolnoslaskie
- Country
- PL
Owner / Operator
- Firm Name
- Wismed PL Sp. z o.o.
- Operator Number
- 10089892
- Address
- 53-338 Wroclaw, ul. Wielka 31/2
- City
- Wroclaw
- State
- Dolnoslaskie
- Postal Code
- 53-338
- Country
- PL
- Correspondent
- Kira Wisniewski
US Agent
- Business Name
- ACE Medical Company
- Contact Name
- Alex Ebner
- Address
- 2181 Victory Pkwy Ste 302
- City
- Cincinnati
- State
- OH
- ZIP
- 45206
- Country
- US
- [email protected]
- Phone
- 800 8220314
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Connector, Ureteral Catheter | EYK | Class 1 | Gastroenterology, Urology | No | 2025-02-20 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2025-02-20 |
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2025-02-20 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2024-01-19 |
Proprietary Names
Sealing Connector Y-Piece
Sealing Connector Straight Body
Sealing Connector T-Piece
Another Hand
Dual Action Pump
Mini Pillow
Foot Pump v16
Peditrol
Smart Bulb
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility