FDA Registration
Active
🇫🇷 France
Centre de distribution Coloplast Le Plessis Pate
Reg #: 3012649202
·
FEI: 3012649202
·
Expires 2026
Products
13
Proprietary Names
33
Establishment Types
2
Classifications
13
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- Centre de distribution Coloplast Le Plessis Pate
- Registration Number
- 3012649202
- FEI Number
- 3012649202
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Rue Jacqueline Auriol
- City
- Le Plessis-Pate Essonne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K140523
Owner / Operator
- Firm Name
- Coloplast Corp.
- Operator Number
- 8010144
- Address
- 1601 West River Road North
- City
- Minneapolis
- State
- MN
- Postal Code
- 55411
- Country
- US
US Agent
- Business Name
- COLOPLAST CORP
- Contact Name
- Brian Schmidt
- Address
- 1601 West River Road N
- City
- Minneapolis
- State
- MN
- ZIP
- 55411
- Country
- US
- [email protected]
- Phone
- 612 8651177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2014-08-07 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2019-12-26 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2009-05-13 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2017-11-29 |
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2007-07-11 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 1995-02-27 |
| Dilator, Catheter, Ureteral | EZN | Class 2 | Gastroenterology, Urology | No | 2017-11-29 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2017-03-02 |
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2019-02-19 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2022-11-22 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2009-01-15 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2001-12-04 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 1995-08-14 |
Proprietary Names
ReTrace Ureteral Access Sheath
Seldinger Guidewire
Soprano Hybrid Guidewire
Soprano® Dual Flex-PTFE-Nitinol Guidewire with Straight Hydrophilic Tip with Insertion Tool
Soprano®-PTFE-Nitinol Guidewire with Straight Hydrophilic Tip with Insertion Tool
BoNee Needle
Biosoft Duo Double Loop Stent Kit
Vortek Double Loop Ureteral Stents
EasiVac
Orchestra Hydrophilic Guidewire
Chiba needle
NovoFlow Reinforced Ureteral Stent
ImaJin Silicone double loop ureteral stent kits
ImaJin Pyelostent Silicone double loop ureteral stent kits
ImaJin Stenostent Silicone double loop ureteral stent kits
Ureteral Dilators and Percutaneous Nephrostomy Dilators
Isiris ?; Isiris Monitor; Isiris Monitor Fixture; Isiris Monitor adaptor kit type G; Isiris Monitor adaptor kit-typ
Floppy Tip Hydro-Coated Ureteric Catheters
Flush Ureteric Catheters
Ureteric Catheters
Kolibri Percutaneous Nephrostomy Catheters
Kolibri Percutaneous Nephrostomy Kits
Kolibri Direct Puncture Sets
KT RUP
Vortek Single Loop Ureteral Stent
Folysil
Elefant Suction-Irrigation Device
Dormia No Tip
Dornia N-Stone
Dormia DualPerc
Imajin Silicone Hydro-Coated Double Loop Ureteral Stent
Silicone Prostatectomy Catheter
Vortek Hydrocoated Double Loop Ureteral Stent
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device