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

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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
Phone
612 8651177

Products

Device Name Product Code
Endoscopic Access Overtube, Gastroenterology-Urology FED
Endoscopic Guidewire, Gastroenterology-Urology OCY
Endoscopic Injection Needle, Gastroenterology-Urology FBK
Stent, Ureteral FAD
Evacuator, Bladder, Manually Operated FFD
Catheter, Nephrostomy, General & Plastic Surgery GBO
Dilator, Catheter, Ureteral EZN
Cystoscope And Accessories, Flexible/Rigid FAJ
Catheter, Ureteral, Gastro-Urology EYB
Catheter, Nephrostomy LJE
Catheter, Retention Type, Balloon EZL
Lavage, Jet FQH
Dislodger, Stone, Basket, Ureteral, Metal FFL

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