Establishment Registration & Device Listing

Establishment Name	Registration Number	Current Registration Yr
COLOPLAST MANUFACTURING FRANCE, SAS FRANCE	9610711	2024
catheter, nephrostomy, general & plastic surgery - Chiba needle		Manufacturer
dislodger, stone, basket, ureteral, metal - Dormia DualPerc; Dormia No Tip; Dornia N-Stone		Manufacturer
lavage, jet - ELEFANT (TM) Suction-Irrigation Device		Manufacturer
catheter, retention type, balloon - X-flow		Manufacturer
catheter, retention type, balloon - Folysil		Manufacturer
endoscopic guidewire, gastroenterology-urology - Orchestra® Hydrophilic guidewire		Specification Developer
stent, ureteral - Vortek® Double Loop Ureteral Stents		Manufacturer
catheter, ureteral, gastro-urology - Floppy Tip Hydro-Coated Ureteric Catheters; Flush Ureteric Catheters; Ureteric Catheters		Manufacturer
stent, ureteral - Silicone Hydro-Coated Double Loop Ureteral Stent		Manufacturer
endoscopic guidewire, gastroenterology-urology - Seldinger Guidewire		Specification Developer
endoscopic access overtube, gastroenterology-urology - ReTrace Ureteral Access Sheath		Manufacturer
dilator, catheter, ureteral - In-Ka® Ureteral Balloon Dilatation Catheters		Manufacturer
catheter, nephrostomy - In-Ka Percutaneous Balloon Catheter and Amplatz Sheath		Manufacturer
evacuator, bladder, manually operated - EASIVAC		Specification Developer
endoscopic access overtube, gastroenterology-urology - RE-TRACE URETERAL ACCESS SHEATH		Manufacturer
stent, ureteral - NovoFlow Reinforced Ureteral Stent		Manufacturer
stent, ureteral - ImaJin Pyelostent Silicone double loop ureteral stent kits; ImaJin Silicone double loop ureteral stent kits; ImaJin Stenostent Silicone double loop ureteral stent kits		Manufacturer
stent, ureteral - Kolibri Direct Puncture Sets; Kolibri Percutaneous Nephrostomy Catheters; Kolibri Percutaneous Nephrostomy Kits		Manufacturer
catheter, nephrostomy - Kolibri Direct Puncture Sets; Kolibri Percutaneous Nephrostomy Catheters; Kolibri Percutaneous Nephrostomy Kits		Manufacturer
endoscopic injection needle, gastroenterology-urology - BoNee Needle		Manufacturer
stent, ureteral		Manufacturer
dilator, catheter, ureteral - Ureteral Dilators and Percutaneous Nephrostomy Dilators		Manufacturer
stent, ureteral - VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS		Manufacturer
stent, ureteral - Vortek Single Loop Ureteral Stent		Manufacturer

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